Luer-activated valves

ABSTRACT

Luer activated valves are disclosed herein that are capable of being integrated into different types of medical devices, such as, IV catheters, sheath introducers, tear-away sheaths, etc. for the purpose of regulating the passage of fluids and/or devices into and out of such devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 16/289,223,filed Feb. 28, 2019.

FIELD

The present invention relates to an apparatus, system and method forselectively blocking the fluid path or infusion stream of a medicaldevice, particularly related to flushable intravenous (IV) catheters,sheath introducers, tear-away sheaths or in-line intravenous infusionvalves and connectors.

BACKGROUND

Catheters are universally used to administer fluid, medicine orparenteral nutrients, withdraw blood, aspirate an embolism, or monitor apatient in need of medical attention. An over-the-needle catheter isused to access a blood vessel, the needle is withdrawn and IV tubing iscoupled to the proximal end catheter hub via a luer-lock connector. Asthe needle is removed from the catheter, the clinician simultaneouslyplaces a digital pressure on the catheter tube in the vessel toconstrict the fluid path to stop blood leaking from the catheter hubinto the workplace, and in doing so, reduces the probability of a bloodexposure to the clinician. If the clinician fails to constrict the fluidpath, blood is free to flow from the patient and out of the sheath,creating a potential blood exposure for the clinician.

Introducer sheaths and tear-away sheaths are widely used to facilitatevascular or bodily access into a patient. The core or obturator of theintroducer sheath or tear-away sheath is withdrawn leaving the distalportion of the sheath positioned in the patient and the proximal end ofthe sheath outside the patient. Some tear-away sheaths include duck-billvalves in an attempt to limit blood loss. However, blood typically leaksthrough the sheath.

Fluids administered to a patient through an IV catheter are deliveredthrough a series of tubes, connectors and valves. In-line infusion, orneedleless valves and connectors are classified in use as: split septum(creates negative displacement); capped luer (creates negativedisplacement); mechanical valve (creates negative displacement); andsurface septum (creates positive displacement). Negative or positiveendolumenal displacement in the fluid path is well known in the medicalliterature to cause catheter occlusion via blood reflux.

A number of safety IV catheters now include a luer-activated valvecomprising a longitudinally movable piston, co-operable resilientduck-bill or split septum membrane positioned orthogonally to the pistonaxis, requiring these split septum flaps to be stored in a stressed ordeformed state the entire time the needle resides in the catheter hub.This means the flaps are deformed from the time components are assembleduntil the device is used. Resilient material takes a “set” when it ispositioned in a configuration that differs from its original formedconfiguration. With an extended shelf life of up to 5 years, thematerial integrity of the split septum flaps degrades and fatiguessignificantly, and performs poorly and leaks when the needle is finallyremoved after the IV catheter is advanced into the patient. The movementof the piston also displaces fluid in the fluid path, creating positiveendolumenal pressure when the piston moves distally, and creating anegative endolumenal pressure when the piston moves proximally,increasing the probability of catheter occlusion. These splitseptum/piston valves also require the catheter hub dimensions to beincreased, both outside diameter and length, adding mass to the device,adding bulk to the packaging and medical waste stream, and altering theclinician's proprioception associated with IV catheter placement.

SUMMARY

According to one implementation a luer-activated valve is provided thatallows the clinician to selectively occlude or close, or open the fluidpath of a flushable IV catheter, sheath introducer, tear-away sheath orin-line infusion connector valve multiple times without creating apositive or negative displacement within the fluid path of the device.

According to some implementations a luer-activated valve of unitaryconstruction (i.e. made from a single piece of material) is provided.According to some implementations a luer-activated valve is providedthat includes a deformable, resilient elongate member having a throughpassage or fluid path that can be selectively opened with the use of aluer fitting and transitions to a closed position to occlude blood flowthrough the valve by removing the needle or luer fitting from the valve.According to some implementations the luer-activated valve is adisplacement-neutral valve and is stored in a non-stressed or relaxedstate, automatically blocking the fluid path when the needle is removedfrom an IV catheter hub, selectively opens when a male luer connector isinserted into the catheter hub, selectively closes when the luerconnector is removed, and functions multiple times when a male luerconnector is inserted or removed from the catheter hub.

According to some implementations the luer-activated valve reducesassembly cycle time and simplifies the assembly process and insures thetip of the needle remains sharp because it is not touched or damagedduring assembly.

According to one implementation the valve includes a clamping memberthat is triggered by an actuator when a needle or luer hub is positionedwithin the catheter hub. In a first position, the clamping member isretained on a distal wall portion of the actuator and does not contactthe exterior wall of the through passage of resilient member of theluer-activated valve. The second position is created when the needle andneedle hub are inserted in the IV catheter hub, engaging the moveableferrule or actuator to release the clamping member from a first retainedposition, to a second ready-to-use position where a compressive radialforce is placed on the resilient elongate tube of the luer-activatedvalve. When the needle is removed from the catheter hub, the clampingarms or segments move to a third position, squeezing the elongate tubeand closing the fluid path. The compressive force of the clamping armsor segments is selectively releasable when the distal end of a luerconnector engages the clamping arms and opens the luer-activated valve.

According to other implementations, a luer-activated valve is providedthat includes a clamp co-operable with a resilient elongate member.According to some implementations, a luer-activated valve is providedthat includes a resilient member, a clamp and an actuator. According tosome implementations, a valve is provided that comprises a metal clipwith opposing arms co-operable with a male luer connector to open orclose the fluid path of a resilient elongate member. According to someimplementations, a luer-activated valve is provided that comprises asub-assembly having an open, un-restricted through passage. According tosome implementations, a valve is provided that comprises a base, amid-section valve and opposing arms co-operable with a male luerconnector to selectively open or close the fluid path of the valve.

These and other implementations along with their advantages and featureswill become evident in view of the drawings and the detaileddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a cross-sectional side view of a ready-to-use IV catheteraccording to one implementation having a luer-activated valve in a firstposition with the needle of the IV catheter passing through theluer-activated valve.

FIG. 2A shows a cross-sectional side view of the luer-activated valve ofFIG. 1 in a second position with the needle removed, having anobstructed, clamped or closed fluid path.

FIG. 2B shows a rear view of the luer-activated valve shown in FIG. 2Aalong axis AA.

FIG. 3A shows a cross-sectional side view of the luer-activated valve ofFIG. 1 in a third position having an unobstructed, or open fluid pathwhen a luer-tipped connector is placed within the IV catheter hub.

FIG. 3B is an isometric, cross-sectional view of the luer-activatedvalve of shown in FIG. 3.

FIG. 4A is a cross-sectional stand-alone side view of the luer-activatedvalve in a first open position.

FIG. 4B is a cross-sectional side view of the luer-activated valve in aclosed position.

FIG. 4C is a cross-sectional stand-alone side view of the luer-activatedvalve in a second open position.

FIG. 5A shows a cross-sectional side view of a ready-to-use IV catheterhaving a luer-activated valve in a first, retained position with aspring clip placing a compressive, clamping force on a resilientelongate tube that is in fluid communication with the catheter tube.

FIG. 5B shows a rear view of the luer-activated valve shown in FIG. 5Ain the IV catheter in axis BB in a first, retained position with theneedle passing through the luer-activated valve.

FIG. 5C is a side cross-sectional view of a luer activated valve locatedinside an IV catheter, the luer activated valve acting on a tubularprojection of a valve plug.

FIG. 6A shows a cross-sectional side view of the luer-activated valve ofFIG. 5A in a closed position with the needle removed, having anobstructed, clamped or closed fluid path.

FIG. 6B shows a rear view of the luer-activated valve shown in FIG. 6Ain the IV catheter in axis CC in the closed position.

FIG. 6C is a side cross-sectional view of a luer activated valve locatedinside an IV catheter, the luer activated valve acting on a tubularprojection of a valve plug to effectuate a closing an internal throughlumen located inside the tubular projection.

FIG. 7 shows a cross-sectional side view of a luer-activated valve in asecond open position having an unobstructed or open fluid path when aluer fitting is placed within the IV catheter hub.

FIG. 8 shows an isometric, cross-sectional view of a luer-activatedvalve of FIG. 7 having an open fluid path.

FIG. 9A is a stand-alone cross-sectional side view of the spring clip inan open position.

FIG. 9B is a stand-alone cross-sectional side view of the spring clip ina closed position.

FIG. 10A shows a cross-sectional view of a proximal portion of theresilient elongate tube.

FIG. 10B shows a cross-sectional view of the distal end portion of thecatheter tube.

FIG. 11 shows an exploded isometric view of an IV catheter without aneedle according to another implementation.

FIG. 12 is a cross-sectional side view of a valve plug according toanother implementation.

FIG. 13A is a cross-sectional side view of a valve clamp in anon-radially expanded state according to one implementation.

FIG. 13B is a cross-sectional side view of the valve clamp in a radiallyexpanded state according to one implementation.

FIG. 14A shows a side view of a valve actuator according to oneimplementation.

FIG. 14B is a cross-sectional side view of the valve actuator of 14A.

FIG. 14C is a proximal end view of the actuator shown in FIGS. 14A and14B.

FIG. 14D is an isometric view of the valve actuator of FIGS. 14A and14B.

FIG. 14E is a side view of an actuator according to anotherimplementation.

FIG. 15A shows a cross-sectional side view of a luer-activated valvehaving an axial through-hole with a clamping device in a first, retainedposition within an IV catheter hub before a needle is coaxiallyintroduced into the IV catheter.

FIG. 15B shows a cross-sectional side view of the luer-activated valveof FIG. 15A having an annular rigid plate disposed between the clampmember and the proximal facing wall of the valve plug.

FIG. 16 shows a cross-sectional side view of a needle coaxially locatedin the luer-activated valve of FIG. 15A in a second, retained positionplacing a clamping force on a resilient elongate tube through which aneedle passes.

FIG. 17 shows a side view of the luer-activated valve shown in FIG. 15Ain a third position (i.e. closed position) having a closed fluid path.

FIG. 18 shows a side view of the luer-activated valve shown in FIG. 15Ain a fourth position having an unobstructed fluid path when a luerconnector is placed within the IV catheter hub.

FIG. 19A shows a side view of a valve actuator according to anotherimplementation.

FIG. 19B is a cross-sectional side view of the valve actuator of 19A.

FIG. 19C is a proximal end view of the actuator shown in FIGS. 19A and19B.

FIGS. 20 and 21 show an IV catheter in different operational states thatincorporate the actuator of FIGS. 19A-C.

FIG. 22A shows a side view of a valve actuator according to anotherimplementation.

FIG. 22B is a cross-sectional side view of the valve actuator of 22A.

FIG. 23 is a cross-sectional side view of an IV catheter havingincorporated therein the valve actuator of FIGS. 22A and 22B.

FIG. 24A shows a cross-sectional side view of an IV catheter having aluer-activated valve having an axial through-hole with a spring memberin a first, retained position within an IV catheter hub before a needleis coaxially introduced into the IV catheter.

FIG. 24B shows a cross-sectional side view of the luer-activated valveof FIG. 24A having an annular rigid plate disposed between the distalend of the spring member and the proximal facing wall of the valve plug.

FIG. 25 shows a cross-sectional side view of a needle coaxially locatedin the luer-activated valve of FIG. 24A in a second, retained positionwith the distal end segments of the spring member placing clampingforces on a resilient elongate tube through which a needle passes.

FIG. 26 shows a side view of the luer-activated valve shown in FIG. 24Ain a third position (i.e. closed position) having a closed fluid path.

FIG. 27 shows a side view of the luer-activated valve of FIG. 24 in afourth position having an unobstructed fluid path when a luer tippedconnector is placed within the IV catheter hub.

FIG. 28 is a cross-sectional side view of the IV catheter of FIG. 24Ahaving incorporated therein the valve actuator of FIGS. 22A and 22B.

FIGS. 29A-C show alternative views of the spring member and valve plugwith the valve in the closed position as depicted in FIG. 26.

FIGS. 30A and 30B are cross-sectional side views of an IV cathetersimilar to that of FIG. 25 having incorporated therein a needle guard.

FIGS. 31A and 31B are cross-section side views of an IV catheter havingincorporated therein a spring clip needle guard.

FIGS. 32A-G illustrate a method of loading a valve assembly into the hubof an IV catheter with the use of a mandrel.

DETAILED DESCRIPTION

A number of luer-activated valves are disclosed herein. In the followingdescription, numerous specific details are set forth in order to providea thorough understanding of the present invention. However, it will beobvious to one of ordinary skill in the art that the invention may bepracticed without these specific details. In other instances, well-knownstructures and processing steps have not been shown in particular detailin order to avoid unnecessarily obscuring the present invention.Additionally, it should be noted that the invention is applicable to avariety of hypodermic devices and infusion devices such as IV catheters,sheath introducers, tear-away sheaths or in-line infusion valves. It isappreciated, however, that the present invention is not limited to thesedevices.

It is understood that the luer-activated valves disclosed herein inregard to IV catheters can easily be adapted to all types of otherdevices where a needle or guidewire may be used, including, but notlimited to, sheath introducers, tear-away sheaths, or in-line infusionvalves and connectors. The luer-activated valves disclosed herein in usewith an IV catheter can also be easily adapted to an endovascularneedle, or other needles used in invasive procedures.

FIG. 1 illustrates a cross-sectional side view of a ready-to-useover-the-needle, flushable IV catheter 10 having luer-activated valve 20in a first retained position with a hollow bore needle 30 extendingthrough the luer-activated valve. According to some implementations theneedle 30 includes an inner lumen 32 and a distal sharpened, beveled tip34. A proximal end portion 36 of needle 30 is attached to a needle hub38. According to one implementation the needle hub 38 includes agas-permeable portion 39 for venting air as blood fills the catheter hub11. The catheter hub 11 includes a flashback chamber 12 and has at itsproximal end a proximal luer flange 13 for attaching a luer-lockfitting. The catheter 10 includes a polymeric hollow catheter tube 14that, according to one implementation, is press fit in the distal end ofhub 11 over ferrule 16. According to one implementation the proximalluer flange 13 is configured to facilitate an attachment of a male luerfitting 40 to the catheter hub 11 as shown in FIGS. 3A and 3B.

The luer-activated valve 20 is located inside the catheter hub 11 andincludes a proximal flange portion 21, a distal flange portion 22 and atubular portion 23 a tubular part extending between the proximal anddistal flanges. The valve 20 is configured to assume an open position asshown in FIGS. 1, 3A and 3B and a closed position as shown in FIGS. 2Aand 2B. According to one implementation the valve 20 is made of aresilient polymeric material and constructed such that the valve iscontinuously urged toward the closed position.

In use, valve 20 has first and second open positions. The first openposition is shown in FIG. 1 wherein the inner walls of the tubularportion of the valve 20 are pressed outward as a result of the needle 30passing therethrough. When the needle 30 is removed from the IV catheter10, the valve 20 automatically transitions to the closed position asshown in FIGS. 2A and 2B due to the resilient nature of the tubularportion 23. In the closed position a part of the tubular portion 23 ofthe valve 20 is caused to close on itself as shown in FIG. 2A. Accordingto one implementation, the outer diameter of the needle 30 and the innerdiameter of the tubular portion 23 of the valve 20 are dimensioned tocause the inner walls 80 and 81 (see FIG. 4A) of the tubular portion 23of the valve to press against the outer surface of the needle 30 toprevent the passage of blood between them. FIGS. 4A and 4C are enlargedcross-section views of the valve 20 respectively shown in the first andsecond open positions. FIG. 4B is an enlarged cross-section view of thevalve 20 shown in the closed position.

When valve 20 is in the closed position it is capable of assuming thesecond open position as shown in FIGS. 3A and 3B upon there being adistally applied force to a proximal face 21 a of the proximal flange21, the valve transitions from the closed position to the second openposition and subsequently returns to the closed position when thedistally applied force is removed. In the second open position fluidflow is permitted through an opening 25 that extends through theproximal and distal flanges and the tubular part. When valve 20 is inthe closed position fluid flow is impeded by a closing of the opening25.

The valve 20 is in a rest position when the valve assumes the closedposition. According to one implementation the proximal flange 21includes first and second wing portions 21 b and 21 c. According to oneimplementation one or both of the wing portions 21 b and 21 c ispositioned at an angle α₁ with respect to the valve's longitudinal axis75 when the valve 20 in the first open position as shown in FIG. 4A andan angle α₂ when the valve is in the closed position as shown in FIG.4B, the angle α₁ being greater than α₂. When the valve 20 is in thesecond open position one or both of the wing portions 21 b and 21 c ispositioned at an angle α₃ with respect to the longitudinal axis 75 ofthe valve 20 as shown in FIG. 4C with angle α₃ being greater than α₂.According to one implementation α₃ is also greater than α₁. When thevalve 20 is in either the first or second open position, the change inangular orientation of the wing portions 21 b and 21 c occursautomatically due to the resilient nature of the valve.

According to one implementation, valve 20 is positioned at the distalend of the catheter hub 11 such that the distal face 22 a of the distalflange 22 faces the inner distal wall 15 of the catheter hub. In theimplementation shown in FIGS. 1-3B the distal face of the distal flange22 abuts a portion of the ferrule 16 located inside the catheter hub,the ferrule being interposed between distal face of the flange and theinner distal wall of the catheter hub 11. According to oneimplementation the distal flange 22 of valve 20 is held in the distalend portion of the catheter hub 11 by a rigid annular lip 5 protrudingradially inward from an inner wall of the catheter hub. When valve 20 isinitially introduced into the catheter hub 11, the distal flange 22 isendowed with sufficient flexibility to allow it to deform sufficientlyto pass across the annular lip 5. When the distal flange 22 has passedacross the annular lip 5 it then, by its resilient nature, returnstowards its initial unstressed state and works in conjunction with theannular lip 5 to hold the valve in place inside the catheter hub 11without the need to use an adhesive. According to one implementation,after placement of the valve 20 inside the catheter hub 11, the distalflange 22 and annular lip 5 further function together to form an annularleak tight seal between them.

According to one implementation the valve 20 is molded part of a unitaryconstruction. That is, it is made of a single piece of material. One orboth of the proximal and distal flanges 21 and 22 may be formed ortreated in any of a number of ways to provide them with a higherrigidity than that of the tubular portion 23. This has severaladvantages. By enhancing the rigidity of the distal flange 22 it can bemore securely fixed inside the catheter hub 11 making it more difficultto proximally move the distal flange across the annular lip 5 inside thecatheter hub. By enhancing the rigidity of the proximal flange 21, itcan safeguard against a folding of the flange on itself to ensure asufficient amount of force is capable of being applied to the proximalflange by the male luer connector to cause the opening of the tubularportion 23 of the valve when the distally applied force is applied tothe proximal flange.

FIG. 1 illustrates the IV catheter 10 in a ready-to-use state with theneedle hub 38 attached to the proximal end of the catheter hub 11 andthe introducer needle 30 passing through the through opening 25 of valve20 and through the catheter tube 14. The sharpened distal tip 34 of theneedle 30 extends beyond the distal end of the catheter tube 14.

After the catheter tube 14 has been properly placed inside a vein oranother part of the patient, the needle 30 is withdrawn by decouplingthe needle hub 38 from the catheter hub 11 and withdrawing the needlefrom the device so that thereafter the assembly of FIG. 2A is produced.As discussed above, as the needle 30 is withdrawn from the throughopening 25 of the valve 20, the valve transitions from the first openposition as shown in FIG. 1 to the closed position as shown in FIGS. 2Aand 2B. Thereafter, fluids may be withdrawn from or administered to thepatient through the indwelling catheter tube 14. According to oneimplementation this is accomplished by introducing a male luer fitting40 into the catheter hub 11 as shown in FIGS. 3 and 4. The male luerconnector 40 includes a part 41 (e.g. threads) that cooperates with theproximal luer flange 13 of the catheter hub to secure the luer connectorto the catheter hub. The luer fitting 40 also includes an internalthrough lumen 42 that is placed into fluid communication with thecatheter tube 14 through the valve 20 when the valve has transitionedfrom the closed position to the second open position.

As the male luer fitting 40 is introduced into the catheter hub 11, itsdistal end surface 43 makes contact with the wings 21 b and 21 c of theproximal flange 21 to cause the wings 21 b and 21 c to flex distallyfrom the first angular position α₂ with respect to the longitudinal axis75 to a second angular position α₃ with respect to the longitudinal axis75 as discussed above. The valve 20 is constructed such that as thewings 21 b and 21 c are forced toward and to the second angular positionby the distally applied force applied to them by the distal end surface43 of the luer connector 40, a through passage 25 is established throughthe valve 20 to place the catheter tube 14 and the inner lumen 42 of theluer connector 40 in fluid communication. When the luer fitting 40 issubsequently removed from the catheter hub 11, the assembly of FIG. 2Ais automatically reestablished with the valve 20 reassuming the closedposition. According to some implementations the outer diameter of themale luer fitting 40 and the inner diameter of the catheter hub 11 aredimensioned such that when the fitting 40 is positioned inside thecatheter hub to cause an opening of the valve 20, a fluid seal isestablished between the outer circumferential surface of the fitting 40and the inner wall of the catheter hub.

According to one implementation valve 20 is positioned at a distal endsection of the catheter hub 11 without freedom of rotation. This can beachieved by establishing a press-fit relationship between the outercircumferential surface of the distal flange 22 and the inner wall ofthe catheter hub 11. One or more projections extending radially inwardfrom the inner wall of the catheter hub 11 and acting on the distalflange 22 of the valve 20 may alternatively be provided to inhibit orprevent rotation of the valve 20 during the male luer 40 being advanceinto or out of the catheter hub 11. The distal face 22 a of the distalflange 22 of valve 20 may additionally or alternatively be roughened.

As discussed above, FIGS. 2A and 2B illustrate the valve 20 in theclosed position. To assist in facilitating a separating and bringingtogether of the inner walls of the tubular portion 23 of the valve, theproximal flange 21 may be provided with first and second slits 51 a and51 b that each extend partially radially inward form an outercircumference of the proximal flange.

FIGS. 5A-10B illustrate other implementations of a luer-activated valve120. In the examples of FIGS. 5A-8 the valve 120 is shown being a partof an IV catheter 100.

FIG. 5A illustrates a cross-sectional side view of a ready-to-useover-the-needle, flushable IV catheter 100 having luer-activated valve120 in a first retained position with a hollow bore needle 130 extendingthrough the luer-activated valve. According to some implementations theneedle 130 includes an inner lumen 132 and a distal sharpened, beveledtip 134. A proximal end portion 136 of needle 30 is attached to a needlehub 138. According to one implementation the needle hub 138 includes agas-permeable portion 139 for venting air as blood fills the catheterhub 111. The catheter hub 111 includes an inner cavity 18 terminating ata proximal luer flange 113. The catheter 100 includes a hollow cathetertube 114 that has a proximal portion 114 a residing inside the catheterhub 111 and a distal portion 114 b that resides distal to the catheterhub. A segment 114 c of the catheter tube 114 is fixed to the catheterhub 111 in a leak-tight manner. The distal-most end of the catheter hub111 may include an elongate conduit 150 inside which the catheter tubesegment 114 c resides and is fixed. According to one implementation theproximal luer flange 113 is configured to facilitate an attachment of amale luer fitting 140 as shown in FIG. 7.

The luer-activated valve 120 is located inside the catheter hub 111 andcomprises a spring clip 121 and the proximal portion 114 a of thecatheter tube 114. The valve 120 is configured to assume a first openposition as shown in FIGS. 5A and 5B, a second open position as shown inFIGS. 7 and 8, and a closed position as shown in FIGS. 6A and 6B.According to one implementation the spring clip 121 is made of a metal(e.g. stainless steel) and the proximal portion 114 a of the cathetertube is made of a resilient polymeric material. The proximal portion 114a is constructed such that it has an ability to be pinched closed by thespring clip 121 as shown in FIGS. 6A and 6B and is thereafter able toautomatically assume an open position as shown in FIGS. 7 and 8 when thespring clip 121 seizes to pinch the proximal portion 114 a.

FIG. 9A shows an enlarged cross-section view of the spring clip 121 inthe second open position. FIG. 9B shows an enlarged cross-section viewof the spring clip 121 in the closed position.

The spring clip 121 includes a base 122 having a through opening 123through which a section of the proximal portion 114 a of the cathetertube passes. The spring clip 121 includes first and second arms 124 and125 that are positioned about the outer surface 116 of the proximalportion 114 a of the catheter tube. Each of the first and second arms124 and 125 respectively includes a first section 126 and 127 having adistal end 126 a and 127 a and a proximal end 126 b and 127 b. Thedistal end 126 a of the first section 126 of arm 124 is coupled to thebase 122 with the proximal end 126 b of the first section 126 beingdisposed radially inward of the distal end 126 a of the first section126 with respect to the longitudinal axis 175. In a similar manner, thedistal end 127 a of the first section 127 of arm 125 is coupled to thebase 122 with the proximal end 127 b of the first section 127 beingdisposed radially inward of the distal end 127 a of the first sectionwith respect to the longitudinal axis 175.

Each of the first and second arms 124 and 125 respectively includes asecond section 128 and 129 located proximally to first sections 126 and127. The second section 128 of the first arm 124 has a distal end 128 aand a proximal end 128 b with the distal end 128 a being coupled to theproximal end 126 b of the first section 126 of the first arm 124 to forma first pinching site 160. The proximal end 128 b of the second section128 is disposed radially outward of the distal end 128 a of secondsection 128 with respect to the longitudinal axis 175. The secondsection 129 of the second arm 125 has a distal end 129 a and a proximalend 129 b with the distal end 129 a being coupled to the proximal end127 b of the first section 127 of the second arm 125 to form a secondpinching site 161. The proximal end 129 b of the second section 129 isdisposed radially outward of the distal end 129 a of second section 128with respect to the longitudinal axis 175.

Each of the first and second arms 124 and 125 is made of a resilientmaterial and constructed such that the first and second pinching sites160 and 161 are continuously urged radially inward toward one another toposition the valve in the closed position. In the closed position of thevalve 120, the first and second pinching sites 160 and 161 press againstopposite sides of the outer surface 116 of the proximal portion 114 a ofthe catheter tube 114 with a force sufficient to cause the tubular wallof the proximal portion 114 a to collapse as shown in FIGS. 6A and 6B tocause a full or substantially full closing of the inner lumen 118 of theproximal tube portion 114 a.

In the second open position of the valve 120, as shown in FIGS. 7 and 8,the first and second pinching sites 160 and 161 are positioned radiallyapart from one another so as not to press against the outer surface ofthe proximal portion of the catheter tube 114 a to permit an opening ofthe inner lumen 118 of the proximal catheter tube portion 114 a. Asdiscussed above, the proximal portion 114 a of the catheter tube is madeof a resilient material that allows the inner lumen to automaticallyexpand from the closed position as shown in FIG. 6A to a full or partialopen position as shown in FIGS. 7 and 8.

FIGS. 5A and 5B show the valve 120 in the first open position when theIV catheter 100 is in a ready-to-use state with the introducer needle130 residing inside the catheter tube 114 with its distal sharpened tip134 extending distally to the distal-most end of the catheter tube.According to one implementation, in the first open position of valve 120the first and second pinching sites 160 and 161 press against the outersurface 116 of proximal portion 114 a of the catheter tube 114 while theinner lumen 118 of the proximal portion 114 a of the catheter tube ismaintained open by a passing of the introducer needle 130 through theinner lumen 118. That is, the outer circumferential surface of theneedle shaft acts on the inner luminal wall of the proximal catheterportion 114 a to maintain the inner lumen 118 open.

According to one implementation, the outer diameter of the needle 130and the inner diameter of the proximal portion 114 a of the cathetertube 114 are dimensioned to cause the inner walls of the proximalportion 114 a to press against the outer surface of the needle 30 toprevent the passage of blood between them.

When the needle 130 is removed from the IV catheter 100, the valve 120automatically transitions to the closed position as shown in FIGS. 6Aand 6B due to the resilient nature of the spring clip arms 124 and 125.

When valve 120 is in the closed position as shown in FIGS. 6A and 6B, itis capable of assuming the second open position, as shown in FIGS. 7 and8, upon there being a distally applied force F to the second sections128 and 129 of the first and second arms 124 and 125 of spring clip 121.When the distally applied force F is subsequently removed, the valve 120automatically returns to the closed position.

According to one implementation, one or both of the first and secondsections 128 and 129 of arms 124 and 125 is position at an angle β₁ withrespect to the longitudinal axis 175 of the clip when the valve 120 isin at least one of the first and second open positions. When the valveis in the closed position one or both of the first and second sections128 and 129 of arms 124 and 125 is positioned at an angle β₂ withrespect to the longitudinal axis 175 of the spring clip 121 as shown inFIG. 9B, the angle β₁ being greater than the angle β₂.

According to one implementation, spring clip 121 is positioned at thedistal end of the catheter hub 111 such that the distal face 122 a ofthe spring clip base 122 faces the distal inner wall 115 of the catheterhub 111. According to one implementation the base 122 is held tight orfixed to the base 115 of the catheter hub 111 without freedom ofrotation.

According to one implementation the spring clip 121 is unitarilyconstructed. That is, it is made of a single piece of material.

As explained above, FIG. 5A illustrates the IV catheter 100 in aready-to-use state with the needle hub 138 attached to the proximal endof the catheter hub 111 and the introducer needle 130 passing though thevalve 120 and catheter tube 114.

After the catheter tube 114 has been properly placed inside a vein oranother part of the patient, the needle 130 is withdrawn by decouplingthe needle hub 138 from the catheter hub 111 and withdrawing the needlefrom the device so that thereafter the assembly of FIG. 6A is produced.As discussed above, as the needle 130 is withdrawn, the valve 120transitions from the first open position as shown in FIGS. 5A and 5B tothe closed position as shown in FIGS. 6A and 6B. Thereafter, fluids maybe withdrawn from or administered to the patient through the indwellingcatheter tube 114 located inside the patient. According to oneimplementation this is accomplished by introducing a male luer fitting140 into the catheter hub 111 as shown in FIGS. 7 and 8. The male luerfitting 140 includes a part 141 (e.g. threads) that cooperates with theproximal luer flange 113 of the catheter hub 111 to secure the luerconnector to the catheter hub. The luer connector 140 also includes aninternal through lumen 142 that is placed into fluid communication withthe catheter tube 114 through the valve 120 when the valve hastransitioned from the closed position to the second open position. Inthe implementation of FIGS. 5A-8, the valve 120 is comprised of thespring clip 121 and the proximal portion 114 a of the catheter tube 114on which the spring clip acts.

As the male luer fitting 140 is introduced into the cavity of thecatheter hub 111, its distal end surface 143 makes contact with thesecond sections 128 and 129 of the arms 124 and 125 of spring clip 121to cause the second sections 128 and 129 to flex distally from angularposition β₂ with respect to angular position β₁. The spring clip isconstructed such that as the second sections 128 and 129 of arms 124 and125 are forced to angular position β₁ by the distally applied forceapplied to them by the distal end surface 143 of the luer connector 140,the first and second pinching sites 160 and 161 move radially away fromone another to enable the proximal portion 114 a of the catheter tube114 to automatically open to place the catheter tube 114 and the innerlumen 142 of the luer connector 140 in fluid communication. When theluer connector 140 is subsequently removed from the catheter hub 111,the assembly of FIG. 6A is automatically reestablished with the valve120 assuming the closed position.

As shown in FIG. 7, according to one implementation the luer-activatedvalve 120 further includes a resilient O-ring 170 positioned about thefirst and second pinching sites 160 and 161. The resilient O-ring 170 isdimensioned and positioned on the spring clip 121 in the region of thefirst and second pinching sites 160 and 161 in a manner that results ina continuous compressive force being applied to the arms 124 and 125 ofthe spring clip 121 by the O-ring to assist in urging the valve 120continuously toward the closed position.

As shown in FIGS. 10A and 10B, according to one implementation theproximal portion 114 a of the catheter tube 114 has a wall thickness t1that is less than the wall thickness t2 of the distal portion 114 b. Thereduced wall thickness in the proximal portion 114 a causes it to bemore easily compressed by the spring clip 121. According to otherimplementations the tubular walls of the proximal portion 114 a are madeto have a Shore hardness that is less than the Shore hardness of thetubular walls of the distal portion 114 b of the catheter tube 114.

In the implementations of FIGS. 5A-10B the tubular portion 114 a ofvalve 120 forms a single part with the remaining part of the cathetertube 114. According to other implementations the tubular portion 114 ais not a part of the catheter tube 114, yet is coupled to the cathetertube in a way that places them in fluid communication with one another.

As shown in FIGS. 5C and 6C, according to some implementations theproximal end of the catheter tube 114 does not extend into the innercavity of the catheter hub 111, but is instead coupled to a distal endof the catheter hub. In the implementations of FIGS. 5C and 6C a valveplug 180 is positioned at the internal distal end of the catheter hub111. The valve plug 180 includes a through opening 184 and is arrangedin the catheter hub 111 to substantially place the through opening 184in axial alignment with a proximal end of the catheter tube. The valveplug includes a base 186 having a proximal facing surface 181 and adistal facing surface 182. Extending proximally from the base is atubular projection 183. According to some implementations a recess isprovided in the proximally facing surface 181 in which resides the base122 of the spring clip 121. In FIG. 5C the valve clip 121 is arranged asshown in FIG. 9A so that the first and second pinching sites 160 and 161press against the outer wall of the tubular projection 183, the throughopening 184 of the plug 180 being maintained in an open state as aresult of the needle 130 passing therethrough. In FIG. 6C the valve clip121 is arranged as shown in FIG. 9B with the needle 130 having beenremoved from the IV catheter. With the needle 130 removed from the IVcatheter the first and second pinching sites of the valve clip 121automatically move radially inward towards one another to cause at leasta portion of the through opening extending through the tubularprojection 183 to close.

According to some implementations the valve plug 180 is disposed insidethe catheter hub 111 in a manner that prevents its rotation therein.According to some implementations the valve clip 121 is supported on orin a recess of the valve plug 180 in a manner that prevents or resistsits rotation thereon or therein.

FIG. 11A is an isometric exploded view of an IV catheter 200 without theintroducer needle according to another implementation. The IV catheterincludes a catheter hub 202 having an internal cavity 204 that is influid communication with an elongate polymeric catheter tube 206 thatextends distally from a base 207 of the catheter hub. As will bediscussed in more detail below, according to one implementation theproximal end portion of the catheter tube 206 is secured to the catheterhub 202 by use of a ferrule 208 on which the proximal end of thecatheter tube is press-fit.

The catheter hub 202 has at its proximal end a proximal luer flange 210for attaching a luer-lock fitting. According to one implementation theproximal luer flange 210 is configured to facilitate an attachment of amale luer fitting to the catheter hub 202 is a manner like that shown inFIGS. 3A, 7 and 18.

The IV catheter 200 has a longitudinal axis 201 and includes a valveassembly 220 that comprises a valve plug 230, a valve clamp 240, arestraining element 250, a spring 260 and a valve actuator 270. In use,the valve assembly components function together to regulate the openingand closing of a valve element to respectively permit or prevent thepassage of fluids therethrough. To this end, according to oneimplementation, the valve assembly 220 is transitional from a first openposition to a closed position, and is thereafter transitional betweenthe closed position and a second open position.

FIG. 12 illustrates a cross-sectional side view of the valve plug 230according to one implementation. The valve plug 230 includes a base 231having proximal facing wall 232 and a distal facing wall 233. Theproximal facing wall 232 includes a ring-shaped recess or annularlyconfigured cavity 234 that circumferentially surrounds tubularprojection 235 that extends proximally from the base 231. According toone implementation the tubular projection 235 is circular, and togetherwith the base 231 includes a passage 236 that extends through the valveplug 230. The tubular projection 235 includes opposing outer walls 237 aand 237 b, and opposing inner walls 238 a and 238 b.

According to one implementation at least the tubular projection 235 ismade of an elastomer that enables the opposing outer walls 237 a and 237b to be radially pressed toward one another to cause the opposing innerwalls 238 a and 238 b to come together in a manner that closes passage236. The tubular projection 235 is configured such that when the outerwalls 237 a and 237 b are not being pressed upon, the passage 236resumes a full or partial open configuration. According to oneimplementation the entirety of the plug 230 is made of an elastomer.

According to one implementation the tubular projection 235 is made of afirst material and the remainder of the plug is made of a secondmaterial that has a durometer greater than that of the first material.According to another implementation the tubular projection 235 and plugbase 231 are two separate pieces that can be bonded together.

According to one implementation the plug 230 is unitarily formed (i.e.made of a single piece) by, for example, a molding process.

FIGS. 13A and 13B shows a cross-sectional side view of the valve clamp240 according to one implementation. According to one implementation theclamp 240 is made of an elastomer and includes first and second opposingarms 241 a and 241 b. Each of arms 241 a and 241 b respectively includesan inner clamping surface 242 a and 242 b. According to oneimplementation the outer contour of each of arms 241 a and 241 brespectively includes an indentation 243 a and 243 b to accommodate aplacement and retention of the resilient member 250 about the arms 241 aand 241 b.

FIG. 13A shows a cross-section view of clamp 240 in a rest state withthe distance d2 separating the inner clamping surfaces 242 a and 242 bbeing less than the outer diameter d of the tubular projection 235 ofplug 230. The valve clamp 240 is configured to expand radially outwardto increase the distance between the clamping surfaces 242 a and 242 bwhen forces in the directions of X₁ and X₂ are respectively applied toarms 241 a and 241 b.

FIG. 13B shows a cross-section view of the valve clamp 240 in a stressedstate when the forces in the X₁ and X₂ directions are applied to thearms 241 a and 241 b. In the stressed state the clamp 240 elongates inthe directions X₁ and X₂ to cause the distance d3 between the clampingsurfaces 242 a and 242 b to be greater than or equal to the diameter dof the tubular projection 235 of the plug 230.

In use, the valve clamp 240 resides positioned about the tubularprojection 235 of the plug 230. When the valve clamp 240 is in the reststate the clamping surfaces 242 a and 242 b respectively press inwardagainst the outer walls 237 a and 237 b of the tubular projection 235 tocause the outer walls to deform radially inward sufficiently to cause acoming together of the inner walls 238 a and 238 b as shown in FIG. 17.The coming together of the inner walls 238 a and 238 b causing a closureof the passage 236. Thereafter, the inner walls 238 a and 238 b of thetubular projection 235 may automatically expand outward, due to theirelasticity, to cause a full or partial opening of the passage 136. Thisis accomplished by respectively applying forces to the arms 241 a and241 b of the clamp 240 in the X₁ and X₂ directions to cause the distanced2 between the clamping surfaces 242 a and 242 b to be greater than orequal to the diameter d of the tubular projection 235 of the plug 230.FIGS. 15A, 15B and 16 respectively show the valve 220 in first andsecond open positions with the clamp 240 being in a stressed state. FIG.17 shows the valve 220 in the closed position when the clamp 240 is in arest state.

In regard to the present disclosure, the term “rest state” encompassesany state of the clamp 240 whereby the distance between the clampingsurfaces 242 a and 242 b is less than the outer diameter d of tubularprojection 235 of the plug 230.

In addition, although the tubular projection 235 has thus far beendescribed as having a diameter, other configurations are possible. Forexample, the tubular projection 235 may have a rectangular outer profileand a rectangular inner profile that defines the passage 236. In suchinstances, the notation “d” in FIG. 12 represents the distance betweenthe outer walls 237 a and 237 b and not a diameter.

According to some implementations, to enhance the closing capability ofthe valve clamp 240, a resilient member 250 is disposed about the valveclamp 240 in a manner that continuously urges the clamping surfaces 241a and 241 b inwardly toward one another. As noted above, according toone implementation the outer profile of the valve clamp 240 includes oneach side a recess 243 a and 243 b in which at least portions of theresilient member 250 are retained.

As will be discussed in detail below, the valve actuator 270 is used toalter the state of the valve clamp 240 for the purpose of opening andclosing the valve 220. In doing so, the actuator 270 is arranged in thevalve assembly 220 with freedom of axial movement along the longitudinalaxis 201 in both a distal direction and a proximal direction.

Arranged in the valve assembly 220 is spring 260 that is configured tourge the actuator 270 in the proximal direction. According to oneimplementation the spring is a coil spring made of a resilient polymericor metal material.

FIGS. 14A-D show various views of the actuator 270 according to oneimplementation. The actuator 270 includes a proximal flange 271 having acentral opening 272. Extending distal from the proximal flange 271 is aprolongation 273. According to one implementation a proximal end portion273 a of the prolongation 273 is funnel-shaped and includes a throughopening that communicates the flange opening 272 with a keyhole typeopening 275 located in a distal end portion 273 b of the prolongation.The opening 275 need not be keyhole-shaped and may include an oblongconfiguration 275 a-b and any shaped opening that can accommodate awidening of the tubular projection 235 of the valve plug 230 when it isclamped between the clamping surfaces 242 a and 242 b of clamping member240 as will be discussed in detail below.

According to one implementation, a distal-most end portion of theprolongation 273 includes an annular segment 274 having a length L thatis equal to or less than the depth d1 of the recess 234 located in plug230. It is important to note that segment 274 need not be annular, andmay include other configurations. One such configuration is shown inFIG. 14D wherein the segment 274 possesses a key-shaped outer profile.In any event, according to some implementations, the shape of the recess234 in the valve plug 230 generally corresponds to the shape/outerprofile of the distal-most segment 274 of the valve actuatorprolongation 273. According to some implementations, like those shown inFIGS. 14A-D, the outer profile of the distal-most segment 274 isnon-circular in order to prevent a rotation of the actuator 270 insiderecess 234.

Located proximal to the distal-most segment 274, and located in opposingsides of the distal end portion 273 b of the prolongation, are first andsecond side openings 276 a and 276 b. Each of the first and second sideopenings 276 a and 276 b provides a side passage into the internallongitudinal opening 275 of the distal end portion 273 b of theprolongation. The first and second side openings 276 a and 276 b arerespectively sized to accommodate a passage of the arms 241 a and 241 bof the clamp member 240 into and out of the internal longitudinalopening 275 of the distal end portion 273 b of the prolongation 273, aswill be described in detail below.

Located proximally adjacent to the first and second side openings 276 aand 276 b of the prolongation there respectively includes first andsecond external inwardly tapered walls 277 a and 277 b. As will bedescribed in more detail below, in use, the valve actuator 270 movesproximally and distally in the direction X as shown in FIG. 14B. Thefirst and second external tapered walls 277 a and 277 b are configuredto respectively act on the arms 241 a and 241 b of the clamp member 240to cause an incremented radial separation of the clamp arms from thepositions shown in FIG. 13A to the positions shown in FIG. 13B.

According to some implementations, as shown in FIG. 14E, outer walls ofthe distal segment 274 of the actuator 270 comprise one or moreindentation 299. As will be discussed in more detail below, the one ormore indentations 299 are configured to assist in holding the innersurfaces of clamp 240 on the actuator 270 when the valve assembly 220 isin its first operational state.

In the implementation shown in FIG. 14E the one or more indentations 299have a concaved shape but may possess other shapes that are sufficientfor holding the inner surfaces of clamp 240 on the actuator 270 when thevalve assembly is in its first operational state. It is important tonote that the implementation of FIG. 14D is applicable to allimplementations disclosed herein that comprise an actuator.

FIG. 15A shows a partial cross-sectional side view of IV catheter 200with the valve assembly 220 positioned inside the catheter hub 202. Thecatheter tube 206 is coupled to the distal end of the catheter hub 202by being fitted over an elongate portion 208 b of the ferrule 208.According to one implementation the ferrule includes a first segment 208a that fits flush against an inner wall of the base 207 of the catheterhub 202. According to one implementation, like that shown in FIG. 15A,the distal facing wall 233 of the valve plug 230 in turn fits flushagainst the proximal side of the ferrule 208.

According to some implementations the valve plug 230 is held in placeinside the catheter hub 202 only as a result of being press-fit in thedistal end of the catheter hub 202. According to other implementationsthe valve plug 230 is secured inside the catheter hub 202 by use of anadhesive. According to some implementations, as shown in FIG. 15A, oneor more lips 205 protrude inward from the inner wall of the catheter hub202 and function to hold or assist in holding the valve plug 230 inplace.

As described previously in conjunction with the implementation of FIG.1, prior to use, the IV catheter includes an introducer needle. Theintroducer needle is attached to a needle hub that is fixed to thecatheter hub via a luer connection. In the “ready to use” state theintroducer needle extends through the catheter hub and into the cathetertube with the sharpened distal tip of the needle protruding distallyfrom the catheter tube as shown in FIG. 1. The use of an introducerneedle applies to each of the IV catheter implementations disclosedherein.

FIG. 15A shows the IV catheter 200 prior to the introducer needle beingintroduced therein. In FIG. 15A the valve assembly is shown in a firstoperational state that allows the introducer needle to freely passthrough the valve 220 and into the inner lumen of the catheter tube 206during an assembly of the introducer needle into the IV catheter. Inthis first operational state, as with all operational states of thevalve assembly, a spring 260 may be held between a distal face 278 ofthe valve actuator flange 271 and the proximal facing wall 232 of thevalve plug 230.

In regard to each of the operational states of the IV catheter shown inFIGS. 15A-18, according to some implementations the distal surface 245of the clamp member 240 is positioned on the proximal facing wall 232 ofthe valve plug 230. According to other implementations a rigid annularplate or film 297 is disposed between the distal surface 245 of theclamp member 240 and the proximal facing wall 232 of the valve plug 230as shown, for example, in FIG. 15B. According to some implementationsthe film may comprise a lubricious film applied to the proximal facingwall 232 of the valve plug 230.

According to some implementations the main body of the plug 230 is madeof a first material having a first durometer and the annular plate 297is made of a second material having a second durometer that is greaterthan the first durometer. According to some implementations the proximalfacing surface of the annular plate 297 has a first surface roughnessand the proximally facing wall 232 of the main body of the plug 230 hasa second surface roughness that is greater than the first surfaceroughness.

As explained above, according to one implementation, the clamp member240 is made of a resilient material and is arranged in the valveassembly 220 such that the clamping surfaces 242 a and 242 b arecontinuously urged toward one another. Disposed between the clampingsurfaces 242 a and 242 b is the tubular projection 235 of the valve plug230. Hence, when the clamping surfaces 242 a and 242 b are not beingheld apart by the actuator 270, they are free to move radially inwardtoward one another to respectively press against the outer walls 237 aand 237 b of the tubular projection 235 of the valve plug 230. Asexplained above, a resilient member 250 may be positioned about theclamp member 240 to act on the clamping arms 241 a and 241 b to providean additional force for urging the inner walls 238 a and 238 b of thetubular projection 235 into contact with one another to effectuate aclosing of the valve 220.

According to one implementation spring 260 is a coil spring thatincludes a distal-most coil 261 that is positioned between the outerperipheral surface of resilient member 250 and an inner surface ofcatheter hub 202 as shown in FIGS. 15A-18.

In the first operational state of FIG. 15A, the actuator 270 is in afirst axial position with the distal segment 274 of the actuator 270being disposed between the clamping surfaces 242 a and 242 b and thetubular projection 235 of the valve plug 230, preventing the clampingsurfaces 242 a and 242 b from pressing against the tubular projection.As a result, a through passage is provided through the valve assembly220 to enable an introduction of the introducer needle 209 into the IVcatheter 200 allowing the needle to be threaded through the valvepassageway during the assembly process without the need for a mandrel toopen the passageway. The open passageway allows the needle bevel to movethrough the passageway without being damaged. FIG. 16 shows theintroducer needle 209 assembled in the IV catheter 200. According to oneimplementation the diameter d4 of the distal segment 273 b of theprolongation 273 is greater than the diameter d of the tubularprojection 235 of the valve plug 230.

FIG. 16 shows the IV catheter 200 in a second operational state with theactuator 270 located in a second axial position distal to the firstaxial position. The second operational state corresponds to the “readyto use” state discussed above. When the actuator 270 is in the secondaxial position, the distal end segment 274 of the prolongation 273resides inside the recess 234 of the valve plug 230 allowing theclamping surfaces 242 a and 242 b of the clamp member 240 to moveradially inward to press against the outer walls 237 a and 237 b of thetubular projection 235. Because the introducer needle 209 resides insidethe tubular projection 235, the tubular projection substantiallymaintains its tubular form when the actuator 270 is in the second axialposition.

As shown in FIG. 16, the introducer needle 209 is affixed to a needlehub 203 that resides inside the cavity 204 of the catheter hub 202. Whenthe introducer needle 209 is assembled in the IV catheter 200, thedistal end surface 211 of the needle hub 203 is caused to press againstthe flange 271 of the actuator 270 to cause the actuator to move fromthe first axial position to the second axial position. During theassembly process the needle hub 203 is moved distally in the directionM. According to one implementation the needle hub 203 is equipped with astop 212 that engages with a part of the catheter hub 202 to limit thedistal advancement of the needle hub into catheter hub to ensure orprevent the actuator 270 from being moved distally beyond the secondaxial position. In the example of FIG. 16 the stop 212 comprises one ormore radially extending protrusions that are configured to act against aproximal end surface 213 of the catheter hub 202. According to oneimplementation the stop 212 constitutes threaded part of the needle hub203 that is configured to cooperate with the proximal luer flange 210 ofthe catheter hub 202 to achieve a fixation of the needle hub with thecatheter hub.

According to some implementations, not shown in the figures, the IVcatheter 200 is equipped with a needle guard that is used to cover thedistal sharpened tip of the introducer 209 upon its removal from the IVcatheter. According to some implementations, the needle guard isdisposed between the needle hub 203 and the actuator 270, and may insome instances transmit the force applied by the needle hub to theactuator during an assembly of the introducer needle 209 into the IVcatheter.

With the IV catheter 200 in the “ready to use” state the clinician mayintroduce the catheter tube 206 into a vessel of a patient by puncturingthe skin of the patient and also the wall of the vessel with thesharpened distal tip of the introducer needle 209 followed by anintroduction of the distal end of the catheter tube 206 into the vessel.Upon the catheter tube 206 being successfully introduced into thevessel, the introducer needle is removed entirely from the IV catheterby disconnecting the needle hub from the catheter hub and advancingwithdrawing the needle 209 proximally.

When the introducer needle 209 is removed from inside the tubularprojection 235 of the valve plug 230, the forces exerted by clampingsurfaces 242 a and 242 b are capable of causing the outer walls of thetubular projection 235 to collapse causing the coming together of theopposing inner walls 238 a and 238 b to effectuate a closing of thevalve as shown in FIG. 17. The configuration of FIG. 17 represents athird operational state of the IV catheter 200.

As discussed above, according to some implementations the actuator 270includes a keyhole-shaped opening 275. The keyhole-shaped openingincludes a central opening and first and second lobes 275 a and 275 bthat protrude from opposite sides of the central opening. According tosome implementations, when the tubular projection 235 of the valve plug230 widens when being clamped, portions of the tubular projection extendoutward from the central opening and into the first and second lobes 275a and 275 b. According to some implementations the central opening has acircular shape and the lobes are defined by curved walls.

When the IV catheter 200 is in the third operational state it is poisedto receive a luer connector 290 as shown in FIG. 18 to facilitate aninfusion of a therapeutic fluid into the vessel of the patient. In FIG.18 the IV catheter 200 is shown in a fourth operational state. The luerconnector 290 typically includes an elongate body 291 that extends intothe cavity 204 of the catheter hub 202 as shown in FIG. 18. The luerconnector 290 includes a threaded part 292 that is configured tocooperate with the proximal luer flange 210 of the catheter hub 202 tolock the luer connector in a fixed position inside the catheter hub 202when the IV catheter is in the fourth operational state. As the luerconnector 290 is advanced distally into the cavity of the catheter hub202, at some point its distal end wall 293 makes contact with theproximal flange 271 of the actuator 270 and applies a force F to theactuator to cause the actuator to move in a distal direction to assume athird axial position as shown in FIG. 18. As the actuator 270 is moveddistally toward the third axial position, the first and second externaltapered walls 277 a and 277 b respectively engage the arms 241 a and 241b of the clamp member 240 to cause the clamping surfaces 242 a and 242 bto disengage with the outer walls of the tubular projection 235 of thevalve plug 230 to effectuate an opening of the valve 220. Thereafter,the through passage 236 of the valve plug 230 communicates a throughpassage 292 of the luer connector 290 with the inner lumen of thecatheter tube 206 to enable a therapeutic agent to be administered intothe vessel of the patient.

FIGS. 19A-C depict a valve actuator according to another implementation.The actuator is similar in construction to the actuator described abovein conjunction with the FIGS. 14A-E with the exception that a portion ofthe through passage extending through a central region of the actuatoris designed to have a diameter d7 that is less than the outer diameter dof the tubular projection 235 of the valve plug 230. The funnel-shapedflange opening 272 has a proximal opening 272 a having a diameter d5 anda distal opening having a diameter d6 which is less than d5. Inaddition, the opening 280 that extends across a length of the distalsegment 273 b of the prolongation 273 has a diameter d7 that is greaterthan diameter d6 and less than or equal to diameter d5. As a result ofthe diametric dissimilarities an inner shoulder 282 is formed at thejuncture of openings 272 and 280 as shown in FIG. 19B.

FIGS. 20 and 21 respectively show the IV catheter 200 in the second andfourth operational states and having a valve actuator like that shown inFIGS. 19A-C. In the implementations of FIGS. 20 and 21 the innerdiameter d7 of opening 280 is slightly larger than the outer diameter dof the tubular projection 235 of valve plug 230 to create a sliding fitbetween the actuator and the tubular projection. However, opening 272 bat the junction of openings 272 and 280 is less than the inner diameterof the tubular projection 235, and according to some implementations thediameter d6 opening 272 a is sized to be slightly larger than the outerdiameter of the introducer needle 209 such that a sliding fit existsbetween the actuator and the outer surface of the introducer needleshaft. The funnel-shaped opening 272 at the proximal end of the actuatorin conjunction with the reduced diameter portion 272 b operates to guidethe introducer needle 209 into and through the valve assembly 220 and toplace the introducer needle in concentric alignment with the valveassembly 220.

FIGS. 22A and 22 b respectively show a side view and cross-sectionalside view of a valve actuator according to another implementation. Theactuator is similar in construction to the actuator described above inconjunction with FIGS. 19A-C and additionally includes a proximalprojection 283 that projects proximally from the flange 271. In use,when the luer connector 290 is advanced into the catheter hub 202 toplace the IV catheter 200 in the fourth operational state, as shown inFIG. 23, the proximal projection 283 functions to concentrically alignthe luer connector lumen 294 with the valve assembly 220. The proximalend of the projection 283 includes a tapered lead-in 284 to facilitate amating of the projection 283 inside the lumen of the luer connector.According to one implementation, the outer diameter d8 of the projection283 is slightly less than the inner diameter of the luer connector lumen294 such that a sliding fit exists between the inner wall of lumen 294and the outer wall of projection 283. The concentric alignment of theluer connector 290 with the valve assembly 220 assists in ensuring amore uniform application of force applied by the distal end 293 of theluer connector 290 onto the flange 271 of the actuator. That is, the useof the proximal projection 283 safeguards against there being a skewedrelationship between the luer connector and the flange of the actuatorwhich could result in the valve assembly 220 not functioning properly.

In FIGS. 14C and 19C, the flange 271 of the actuator 270 is shown havingfirst and second curved sides 285 a and 285 b and first and secondstraight sides 286 a and 286 b. This configuration may be included inall actuators disclosed herein. In FIGS. 15-18, 20, 21 and 23 the curvedends 285 a and 285 b of the actuator 272 are shown spaced apart from theinner wall cylindrical wall 215 of the catheter hub 202. According toother implementations the width W of the flange 271, as shown in FIG.14C, is substantially equal to the inner diameter d9 of the catheter hub202 at least when the valve assembly 220 is in the fourth operationalstate in order to produce a close sliding fit between the first andsecond curved sides 285 a and 285 b of the flange 271 and the inner wall215 of the catheter hub 202. According to some implementations thecurvature of the first and second curved sides 285 a and 285 b is thesame or substantially the same as the curvature of the inner wall 215 ofthe catheter hub 202.

According to some implementations the flange 271 has a circular profilein lieu of having curved and straight sides. According to suchimplementations the diameter of the flange 271 is substantially equal tobut less than the inner diameter d9 of the catheter hub 202, at leastwhen the valve assembly 220 is in the fourth operational state, in orderto produce a close sliding fit between the first and second curved sides285 a and 285 b of the flange 271 and the inner wall 215 of the catheterhub 202. According to some implementations the close sliding fit issufficient to limit, at least to some degree, a tilting of the flange271 inside the hub cavity 204.

In FIGS. 15A-18, 20, 21 and 23 the cylindrical inner wall 215 of thecatheter hub 202 is shown tapering inward such that a cross-sectionalview of the hub cavity 204 is cone-shaped having a truncated distal end.In other words, the inner diameter d9 of the cavity 204 diminishes alongthe length of the cavity when moving in the distal direction. Accordingto other implementations at least the length of the cavity 204 locatedproximal to the proximal end of the tubular projection 235 of the valveplug 230 has a uniform inner diameter.

The flange 271 of the actuator 270 has a longitudinal range of motionbetween a proximal-most position inside the hub cavity 204 when thevalve assembly is in the first operational state and a distal-mostposition inside the hub cavity 204 when the valve assembly is in thefourth operational state. According to some implementations at least theinner diameter of the hub cavity 204 between the proximal-most anddistal-most positions is uniform. According to such implementations thewidth W or diameter of the actuator flange 271 is dimensioned such thatthe outer perimeter wall 287 of the flange rides along the inner wall215 of the catheter hub 202 with there being a sliding fit between walls287 and 215.

In order to prevent a rotation of the actuator 270 inside the catheterhub 202, according to some implementations the outer peripheral wall ofthe actuator flange 271 is equipped with one or more notches and theinner wall of the catheter hub 202 is equipped with one or morelongitudinally extending protuberances fitted respectively inside theone or more notches.

FIGS. 24A-27 illustrate an IV catheter 300 according to anotherimplementations. According to some implementations the IV catheter 300is similar to the IV catheter 200 depicted in FIGS. 15A-18 except in theconstruction of the valve assembly 320. The valve assembly 320 includesa valve plug 230 like that described above. The valve assembly alsoincludes a valve actuator 270 like that described above.

The valve assembly 320 differs from valve assembly 220 in that it doesnot include a separate valve clamp 240 or resilient member 250 orhelical spring 260. The valve assembly 320 instead includes a springelement 360 having distal first and second clamping segments 361 a and361 b that are configured to move radially inward and outward torespectively effectuate an opening and closing of the tubular projection235 passage way. The spring clip 360 is held between the distal face 278of the valve actuator flange 271 and the proximal facing wall 232 of thevalve plug 230. The spring clip element 360 includes a proximal endsegment 362 that is configured to be acted upon by the actuator flange271 in order to cause the valve assembly 320 to assume variousoperational states like the first, second, third and fourth operationalstates described above. Additionally, the valve may operate multipletimes between the third and fourth operational positions providingmulti-cycle use. Like spring 260 disclosed above, the spring isassembled in valve assembly 320 such that the spring clip 360continuously urges the actuator 271 in the proximal direction at leastin the second, third and fourth operational states. The proximal endsegment 362 of the spring clip 360 includes first and second ends 362 aand 362 b that are respectively coupled to the first and second clampingsegments 361 a and 361 b by first and second crossing arms 363 a and 363b.

FIG. 24A shows a partial cross-sectional side view of IV catheter 300with the valve assembly 320 positioned inside the catheter hub 202. Thecatheter tube 206 is coupled to the distal end of the catheter hub 202by being fitted over an elongate portion 208 b of the ferrule 208.According to one implementation the ferrule includes a first segment 208a that fits flush against an inner wall of the base 207 of the catheterhub 202. According to one implementation, like that shown in FIG. 24,the distal facing wall 233 of the valve plug 230 in turn fits flushagainst the proximal side of the ferrule 208.

According to some implementations the valve plug 230 is held in placeinside the catheter hub 202 only as a result of being press-fit in thedistal end of the catheter hub 202. According to other implementationsthe valve plug 230 is secured inside the catheter hub 202 by use of anadhesive. According to some implementations, as shown in FIG. 24A, oneor more lips 205 protrude inward from the inner wall of the catheter hub202 and function to hold or assist in holding the valve plug 230 inplace.

As described previously in conjunction with the implementation of FIG.1, prior to use, the IV catheter includes an introducer needle. Theintroducer needle is attached to a needle hub that is fixed to thecatheter hub via a luer connection. In the “ready to use” state theintroducer needle extends through the catheter hub and into the cathetertube with the sharpened distal tip of the needle protruding distallyfrom the catheter tube as shown in FIG. 1. The use of an introducerneedle applies to each of the IV catheter implementations disclosedherein.

FIG. 24A shows the IV catheter 300 prior to the introducer needle beingintroduced therein. In FIG. 24A the valve assembly is shown in a firstoperational state that allows the introducer needle to freely passthrough the valve 320 and into the inner lumen of the catheter tube 206during an assembly of the introducer needle into the IV catheter. Inthis first operational state, as with all operational states of thevalve assembly, the spring clip 360 is held between the distal face 278of the valve actuator flange 271 and the proximal facing wall 232 of thevalve plug 230.

In regard to each of the operational states of the IV catheter 300 shownin FIGS. 24A-27, the first and second clamping segments 361 a and 361 bof spring clip 360 are positioned on the proximal facing wall 232 of thevalve plug 230. According to other implementations a rigid annular plateor film 295 is disposed between the distal surface 245 of the clampmember 240 and the proximal facing wall 232 of the valve plug 230 a asshown, for example, in FIG. 24B. According to some implementations thefilm may comprise a lubricious film applied to the proximal facing wall232 of the valve plug 320.

According to some implementations the main body of the plug 230 is madeof a first material having a first durometer and the annular plate 295is made of a second material having a second durometer that is greaterthan the first durometer. According to some implementations the proximalfacing surface of the annular plate 295 has a first surface roughnessand the proximally facing wall 232 of the main body of the plug 230 hasa second surface roughness that is greater than the first surfaceroughness.

The spring clip 360 is constructed and arranged in the valve assembly320 such that the clamping segments 361 a and 361 b are continuouslyurged toward one another. Disposed between the first and second clampingsegments 361 a and 361 b is the tubular projection 235 of the valve plug230. Hence, when the clamping surfaces 361 a and 361 b are not beingheld apart by the first and second external tapered walls 277 a and 277b of actuator 270, they are free to move radially inward toward oneanother to respectively press against the outer walls 237 a and 237 b ofthe tubular projection 235 of the valve plug 230.

In the first operational state of FIG. 24A, the actuator 270 is in afirst axial position with the distal segment 274 of the actuator 270being disposed between the clamping segments 361 a and 361 b and thetubular projection 235 of the valve plug 230, preventing the clampingsegments 361 a and 361 b of spring clip 360 from pressing against thetubular projection 235. As a result, a through passage is providedthrough the valve assembly 220 to enable an introduction of theintroducer needle into the IV catheter 300 allowing the needle to bethreaded through the valve passageway during the assembly processwithout the need for a mandrel to open the passageway. As discussedabove, the open passageway allows the needle bevel to move through thepassageway without being damaged. FIG. 25 shows the introducer needle209 assembled in the IV catheter 300.

FIG. 25 shows the IV catheter 300 in a second operational state with theactuator 270 located in a second axial position distal to the firstaxial position. The second operational state corresponds to the “readyto use” state discussed above. When the actuator 270 is in the secondaxial position, the distal end segment 274 of the prolongation 273resides inside the recess 234 of the valve plug 230 allowing theclamping segments 361 a and 361 b of the spring clip 360 to moveradially inward to press against the outer walls 237 a and 237 b of thetubular projection 235. Because the introducer needle 209 resides insidethe tubular projection 235, the tubular projection substantiallymaintains its tubular form when the actuator 270 is in the second axialposition.

As shown in FIG. 25, the introducer needle 209 is affixed to a needlehub 203 that resides inside the cavity 204 of the catheter hub 202. Whenthe introducer needle 209 is assembled in the IV catheter 300, thedistal end surface 211 of the needle hub 203 is caused to press againstthe flange 271 of the actuator 270 to cause the actuator to move fromthe first axial position to the second axial position. During theassembly process the needle hub 203 is moved distally in the directionM. According to one implementation the needle hub 203 is equipped with astop 212 that engages with a part of the catheter hub 202 to limit thedistal advancement of the needle hub into catheter hub to ensure orprevent the actuator 270 from being moved distally beyond the secondaxial position. In the example of FIG. 25 the stop comprises one or moreprotrusions 212 that extend radially from the needle hub 203. The one ormore protrusions 212 are configured to act against a proximal endsurface 213 of the catheter hub 202. According to one implementation thestop 212 constitutes a threaded part of the needle hub 203 that isconfigured to cooperate with the proximal luer flange 210 of thecatheter hub 202 to achieve a fixation of the needle hub 203 with thecatheter hub 202.

According to some implementations, as will be discussed in more detailbelow, the IV catheter 300 is equipped with a needle guard that is usedto cover the distal sharpened tip of the introducer 209 upon its removalfrom the IV catheter. According to some implementations, the needleguard is disposed between the needle hub 203 and the actuator 270, andmay in some instances transmit the force applied by the needle hub 203to the actuator 270 during an assembly of the introducer needle 209 intothe IV catheter.

With the IV catheter 200 in the “ready to use” state the clinician mayintroduce the catheter tube 206 into a vessel of a patient by puncturingthe skin of the patient and also the wall of the vessel with thesharpened distal tip of the introducer needle 209 followed by anintroduction of the distal end of the catheter tube 206 into the vessel.Upon the catheter tube 206 being successfully introduced into thevessel, the introducer needle is removed entirely from the IV catheterby disconnecting the needle hub from the catheter hub and advancing theneedle 209 proximally.

When the introducer needle 209 is removed from inside the tubularprojection 235 of the valve plug 230, the forces exerted by the clamping361 a and 361 b of spring clip 360 are capable of causing the outerwalls of the tubular projection 235 to collapse causing the comingtogether of the opposing inner walls 238 a and 238 b to effectuate aclosing of the valve as shown in FIGS. 26 and 29 a-c. The configurationof FIG. 26 represents a third operational state of the IV catheter 300.

As discussed above, according to some implementations the actuator 270includes a keyhole-shaped opening 275. The keyhole-shaped openingincludes a central opening and first and second lobes 275 a and 275 bthat protrude from opposite sides of the central opening. According tosome implementations, when the tubular projection 235 of the valve plug230 widens when being clamped, portions of the tubular projection extendoutward from the central opening and into the first and second lobes 275a and 275 b. According to some implementations the central opening has acircular shape and the lobes are defined by curved walls.

When the IV catheter 300 is in the third operational state it is poisedto receive a luer connector 290 as shown in FIG. 27 to facilitate aninfusion of a therapeutic fluid into the vessel of the patient. In FIG.27 the IV catheter 300 is shown in a fourth operational state. The luerconnector 290 typically includes an elongate body 291 that extends intothe cavity 204 of the catheter hub 202 as shown in FIG. 27. The luerconnector 290 includes a threaded part 292 that is configured tocooperate with the proximal luer flange 210 of the catheter hub 202 tolock the luer connector in a fixed position inside the catheter hub 202when the IV catheter is in the fourth operational state. As the luerconnector 290 is advanced distally into the cavity of the catheter hub202, at some point its distal end wall 293 makes contact with theproximal flange 271 of the actuator 270 and applies a force F to theactuator to cause the actuator to move in a distal direction to assume athird axial position as shown in FIG. 27. As the actuator 270 is moveddistally toward the third axial position, the first and second externaltapered walls 277 a and 277 b of the actuator respectively engage theclamping segments 361 a and 361 b of the spring clip 360 to cause theclamping segments 361 a and 361 b to disengage with the outer walls ofthe tubular projection 235 of the valve plug 230 to effectuate anopening of the valve 320. Thereafter, the through passage 236 of thevalve plug 230 communicates a through passage 292 of the luer connector290 with the inner lumen of the catheter tube 206 to enable atherapeutic agent to be administered into the vessel of the patient.

According to some implementations the actuator 270 includes a proximallyextending tubular part 283 that extends proximally from the flange 271.The proximally extending tubular part 283 is sized to fit inside theinner lumen 294 of the luer connector 290 as shown in FIG. 28 to assistin placing the through passage of the actuator 270 and the lumen 294 ofthe luer connector in coaxial or near coaxial alignment to provide anunobstructed fluid pathway. According to some implementations, to avoidor minimize fluids administered through the luer connector 290 to passdistal to the actuator flange 271, the outer diameter d8 of theproximally extending tubular part 283 and the inner diameter of the luerconnector lumen 294 are sized to produce a close sliding fit betweenthem.

FIGS. 30A and 30B illustrate an IV catheter 400 similar to IV catheter300 according to another implementation in which the sharpened distalend 34 of the introducer needle 209 is capable of being retractedproximally into a first internal chamber 411 of the needle hub 410 asthe needle 209 is removed from the catheter tube 206. FIG. 30A shows thevalve assembly 320 is its second operative state and FIG. 30B shows thevalve assembly 320 in the third operational state.

In use, a trigger or other actuating device associated with the needlehub 410 is operative to evoke a proximal withdrawal of the sharpeneddistal end of the introducer needle 209 into the first internal chamber411 through the use of a coil spring 420 that may be located in a secondinternal chamber 412 of the needle hub 410. As shown in FIGS. 30A and30B, as the valve assembly 320 transitions from the second operationalstate to the third operational state the coil spring 420 axially expandsinside the second chamber 412 to cause a proximal movement of the distalsharpened end 34 of the introducer needle 209 into safe storage insidethe first internal chamber 411, thus adverting a possibility of a userof the IV catheter 400 being stuck by the needle tip 34.

According to one implementation the shaft of the needle just proximal tothe sharpened distal tip 34 is provided with a change in profile (notshown in the figures). The change in profile region of the shaft has awidth dimension (the width dimensional being orthogonal to thelongitudinal axis of the introducer needle 209) that is greater than thediameter dimension of the remainder of the introducer needle. To limitthe withdrawal of the sharpened distal tip 34 proximally beyond thefirst internal chamber 411, an internal wall portion located between orat the juncture of the first and second internal chambers 411 and 412has a cross-sectional profile that is small enough to prevent a passageof the change in profile portion of the needle across the internal wallportion.

FIGS. 31A and 31B illustrate an IV catheter 500 according to anotherimplementation having a needle guard 520 integrated therewith. FIG. 31Ashows the valve assembly 320 is its second operational state and FIG.31B shows the valve assembly 320 in the third operational state.

The needle guard 520 includes a base 521 from which resilient arms 522 aand 522 b distally extend. Each of arms 522 a and 522 b respectivelyincludes a distal end segment 523 a and 523 b that extends radiallyinward toward the shaft of the introducer needle 209. When the IVcatheter is in the ready-to-use state as shown in FIG. 31A, a portion524 a and 524 b of each of segments 523 a and 523 b reside forcedagainst the shaft of the introducer needle 209. According to oneimplementation the needle guard 520 further includes an elongate member525 that extends axially between the base 521 and the distal endsegments 523 a and 523 b of the resilient arms 522 a and 522 b.

The IV catheter assembly 500 also includes a needle hub 530 to which adistal end or distal end portion 531 of the introducer needle 209 isattached. When the IV catheter is in the ready-to-use state a distal endportion of the needle hub 530 is attached to a proximal end portion ofthe catheter hub 202 with a proximal end portion of the introducerneedle 209 passing through a proximal opening in the elongate member 525and an opening in the base 521 of the needle guard. In the ready-to-usestate the introducer needle 209 passes through the needle guard 520, thevalve assembly 320 and into the catheter tube 206 such that thesharpened distal end 34 resides distal to the distal end of the cathetertube 206. When the IV catheter is in the ready-to-use state, the innerwall of the catheter hub 202 may possess one or more inward protrudinglips 528 that are configured to engage with portions 529 a and 529 b ofthe needle guard arms 521 a and 521 b to assist in fixing the axialposition of the needle guard 520 inside the catheter hub 202.

Prior to having assumed the second operational state, the valve actuator270 is forced in a distal direction to cause the distal end segment 274of the actuator to move distally into the recess 234 of the valve plug230. According to one implementation, the distally applied forceoriginates from a distal movement of the needle hub 530 as it is beingattached to the catheter hub 202. As the needle hub 530 moves distally,the distal face 535 of the needle hub engages with the proximal face 526of the needle guard base 521 to cause at least one of the first andsecond distal end segments 523 a and 523 b of arms 522 a and 522 b topress against the actuator flange 271 to cause a movement of the distalend segment 274 of the actuator 271 to move distally into the recess 234of the valve plug 230 to cause the valve assembly to transition from thefirst operational state to the second operational state.

Upon the distal end portion of the catheter tube 206 being successfullyintroduced into a vein of the patient, the clinician may then remove theintroducer needle from the catheter tube 206 as shown in FIG. 31B.Removal is accomplished by detaching the needle hub 530 from thecatheter hub 202 and pulling the needle hub proximally until thesharpened distal end 34 of the needle 209 resides inside a cavity of theelongate member 525 of the needle guard 520. Upon the sharpened distaltip 34 of the needle 209 entering the elongate member 525, the resilientarms a 522 a and 522 b are free to move radially inward toward oneanother to assume the position as shown in FIG. 31B, locking the tip ofthe needle 209 inside the elongate member.

According to one implementation the shaft of the needle just proximal tothe sharpened distal tip 34 is provided with a change in profile (notshown in the figures). The change in profile region of the introducerneedle shaft has a width dimension (the width dimensional beingorthogonal to the longitudinal axis of the introducer needle 209) thatis greater than the diameter dimension of a proximal end portion 525 aof the elongate member 525 in order to limit the withdrawal of thesharpened distal tip 34 proximally beyond the elongate member 525 asshown in FIG. 31B.

When the entirety of the sharpened distal tip 34 of the introducerneedle 209 being located inside the elongate member 525, the distal endportions 523 a and 523 b move radially inward to reside over the distalopening 525 b of the elongate member 525 to lock the sharpened distaltip inside the elongate member. Thereafter, the entirety of the needleguard 520 is removed from the inner cavity of the catheter hub 202 by acontinued proximal withdrawal of the needle hub 530.

Needle guard 520 may be similar to or the same as the needle guardimplementations disclosed in co-owned U.S. Pat. No. 8,764,711 (filedFeb. 28, 2011 and issued Jul. 1, 2014), which is incorporated byreference herein in its entirety.

FIGS. 32A-G show a method of loading the valve assembly 320 in its firstoperational state into catheter hub 202. The method includes the use ofa mandrel 600 that includes an elongate proximal handle 601 that can begripped by an assembler or automated assembly means, during the loadingprocess. Extending distally to the handle 601 are a central pin 603 andtwo or more side arms 604 a and 604 b that at least partially surroundthe central pin 603. In the implementation of FIG. 32D the mandrelincludes two side arms 604 a and 604 b. In the implementation of FIG.32E the mandrel includes four side arms 604 a-d. The mandrel 600 is madeof rigid material that prevents any part of the mandrel from flexingduring an assembling of the valve assembly 320 into the catheter hub.

The assembly process includes assembling together the actuator 270,spring element 360 and plug 230 to form the valve assembly 320 in itsfirst operational state as shown in FIG. 32B. As explained above, whenthe valve 320 is in the first operational state the clamping segments361 a and 361 b of the spring element 360 reside forced against thedistal end segment 274 of the actuator 270 to prevent the clampingsegments 361 a and 361 b from acting on the tubular projection 235 ofthe valve plug 230.

The valve 320 may be pre-assembled before being placed on the mandrel600 or valve 320 may be sequentially assembled on the mandrel 600itself. When the valve 320 is pre-assembled before being placed on themandrel 600, it is done so in its first operational state, being loadedonto the mandrel 600 such that the central pin 603 of the mandrelextends through the through passage 640 of the valve assembly 320 asshown in FIG. 32C. When the valve assembly 320 is fully loaded onto themandrel, the distal ends 605 a and 605 b of the side arms 604 a and 604b are positioned touching the proximal facing wall 232 of the valve plug230 and the distal end 603 a of the central pin 603 protrudes distallyfrom the valve plug 230. According to one implementation the length L1of each of side arms 604 a and 604 b is sufficiently long to ensure agap 609 exists between the actuator 270 and a distal facing wall 608 ofthe mandrel from which the side arms protrude. The existence of the gap609 guards against the actuator 270 being acted on by the mandrel 600 asthe valve assembly 320 is loaded into the catheter hub 202, ensuringthat the valve assembly 320 remains in its first operational stateduring the loading process.

As shown in FIG. 32A, the length L2 of the central pin 603 is greaterthan the length L1 of each of the side arms 604 a and 604 b.

In the implementation of FIG. 32D the flange 271 of the actuator 272 isshown having first and second curved sides 285 a and 285 b and first andsecond straight sides 286 a and 286 b like that shown in FIGS. 14C and19C or in actuator 270. The existence of the first and second straightsides provides a passageway between the outer periphery of the actuatorflange 271 and the inner wall of the catheter hub 202 through which theside arms 604 a and 604 b of the mandrel 600 pass when the valveassembly 320 is introduced into the catheter hub as shown in FIG. 32F.

In the implementation of FIG. 32E the mandrel 600 is equipped with fourprojecting side walls 604 a-d and the actuator flange 271 includes fourstraight sides 286 a-d separated by four curved corners 650 a-d.According to other implementations the mandrel 600 is equipped withthree projecting side walls and the actuator flange 271 includes threestraight sides separated by three curved corners. The use of a mandrelhaving three or more projecting side walls spaced equidistantly about anouter perimeter of the mandrel ensures against a valve assembly 320being skewed in one direction or another during its loading into thecatheter hub.

While the valve assembly 320 is being introduced into the catheter hub202, the distal ends 604 a and 604 b of side arms 603 a and 603 b pressagainst the proximal facing wall 232 of the base 231 of plug 230 toforce the distal facing wall 233 of the plug 230. According to someimplementations the base 231 of the plug 230 is made of a material thatprevents it from deforming during the insertion of the valve assembly320 into the catheter hub 202. Alternatively, the base 231 of the plug230 may be supported on a rigid structure attached to its distal facingwall 233.

As shown in FIG. 32F, the length L2 of the central pin 603 of mandrel600 is sufficiently long such that it extends distally into the innerlumen of the catheter tube 206 when the valve assembly is distallypositioned inside the catheter hub 202. This feature assures a properaxial alignment of the valve assembly 320 inside the catheter hub 202 toensure the valve passageway 640 is properly aligned with the inner lumenof the catheter tube 206.

Upon the valve assembly 320 being fixed inside the catheter hub 202 asshown in FIG. 32F, the mandrel 600 is proximally withdrawn from thecatheter hub such that the IV catheter configuration of FIG. 32G exists,the valve assembly 320 being in its first operational state. Theintroducer needle 209 may thereafter be introduced into the IV catheterassembly as described in detail above.

The following clauses disclose in an unlimited way additionalimplementations. Group A through F clauses are provided.

Group A Clauses:

Clause 1. A valve assembly configured for placement inside a hub thathas a proximal opening, a distal opening and an internal cavity disposedbetween the proximal and distal openings, the cavity defined by one ormore sidewalls and a distal wall of the hub, the distal openingextending through the distal wall, the valve assembly comprising:

a plug made of a resilient material, the plug including a main bodyhaving a proximal facing surface and a distal facing surface, the mainbody including an axial through opening and being configured such thatthe axial through opening is in fluid communication with the distalopening of the hub, the axial through opening extending through atubular part that has a proximal end portion that protrudes proximal tothe proximal facing surface of the main body, there existing a recess inthe proximal facing surface that at least partially surrounds thetubular part;

an actuator including a proximal flange having a proximal facingsurface, the actuator including a distally protruding structure thatextends distal to the proximal flange, there being an axial throughopening that extends through the proximal flange and the distallyprotruding structure, the distally protruding structure having aproximal part, a distal part and a transverse through opening disposedbetween the proximal and distal parts, the distal part having an outerwall, the proximal end portion of the tubular part of the plug residinginside the distally protruding structure; and

a spring member including a proximal end segment and first and secondclamping segments that are operatively coupled to the proximal endsegment respectively by first and second arms, the spring member beingconfigured to cause the first and second clamping segments to moveradially apart from one another when a distally applied force is appliedto the proximal end segment, when the actuator is in a first axialposition the first and second clamping segments are urged against theouter wall of the distal part of the actuator, when the actuator is in asecond axial position distal to the first axial position the distal partof the actuator is configured to move distally into the recess in theproximal facing surface of the main body of the plug and the first andsecond clamping segments of the spring member move radially inward intothe transverse through opening of the actuator to act against theproximal end portion of the tubular part of the plug in a mannersufficient to cause a closing of the axial through opening of the plugin the proximal end portion.

Clause 2. The valve assembly according to clause 1, wherein the proximalpart of the actuator has an outer wall that tapers distally inward, whenthe actuator is in the second axial position the actuator is movabledistally to a third axial position distal to the second axial positionto cause the tapered outer wall of the first part of the actuator to acton the first and second clamping segments in a manner that results inthe first and second clamping segments to move radially outward in amanner sufficient to at least partially open the axial through openingof the plug.

Clause 3. The valve assembly according to clause 1, wherein when theactuator transitions from the first axial position to the second axialposition the actuator is incapable of reassuming the first axialposition.

Clause 4. The valve assembly according to clause 2, wherein when theactuator transitions from the first axial position to the second axialposition the actuator is incapable of reassuming the first axialposition.

Clause 5. The valve assembly according to clause 1, wherein the proximalend segment of the spring member abuts a distal facing surface of theproximal flange of the actuator and each of the first and secondclamping segments abuts the proximal facing surface of the main body ofthe plug.

Clause 6. The valve assembly according to clause 1, wherein the proximalflange of the actuator has a first diameter dimension and the distallyprotruding part of the actuator has a second diameter dimension that isless than the first diameter dimension.

Clause 7. The valve assembly according to clause 1, wherein the axialthrough opening of the actuator comprises a key-hole shape.

Clause 8. The valve assembly according to clause 1, wherein the distalfacing surface of the main body of the plug is configured to abut thedistal wall of the hub.

Clause 9. The valve assembly according to clause 1, wherein a press fitexists between the main body of the plug and the one or more sidewallsof the hub.

Clause 10. The valve assembly according to clause 1, further comprisingan annular plate disposed between the first and second clamping segmentsof the spring member and the proximal facing surface of the main body ofthe plug.

Clause 11. The valve assembly according to clause 10, wherein the firstand second clamping segments of the spring member abuts a proximalfacing surface of the annular plate.

Clause 12. The valve assembly according to clause 11, wherein the mainbody of the plug is made of a first material having a first durometerand the annular plate is made of a second material having a seconddurometer that is greater than the first durometer.

Clause 13. The valve assembly according to clause 11, wherein theproximal facing surface of the annular plate has a first surfaceroughness and the proximally facing surface of the main body of the plughas a second surface roughness that is greater than the first surfaceroughness.

Clause 14. The valve assembly according to clause 12, wherein theproximal facing surface of the annular plate has a first surfaceroughness and the proximally facing surface of the main body of the plughas a second surface roughness that is greater than the first surfaceroughness.

Clause 15. The valve assembly according to clause 1, wherein the outerwall of the distal part of the actuator includes an indentation in whichthe first and second clamping segments of the spring member reside whenthe actuator is in the first axial position, the indentation configuredto assist in holding the first and second clamping segments on thedistal part of the actuator.

Group B clauses:

Clause 1. An intravenous catheter comprising:

a catheter hub that has a proximal opening, a distal opening and aninternal cavity disposed between the proximal and distal openings, thecavity defined by one or more sidewalls and a distal wall of thecatheter hub, the distal opening extending through the distal wall;

a plug made of a resilient material, the plug including a main bodyhaving a proximal facing surface and a distal facing surface, the mainbody including an axial through opening and being configured such thatthe axial through opening is in fluid communication with the distalopening of the hub, the axial through opening extending through atubular part that has a proximal end portion that protrudes proximal tothe proximal facing surface of the main body, there existing a recess inthe proximal facing surface that at least partially surrounds thetubular part;

an actuator including a proximal flange having a proximal facingsurface, the actuator including a distally protruding structure thatextends distal to the proximal flange, there being an axial throughopening that extends through the proximal flange and the distallyprotruding structure, the distally protruding structure having aproximal part, a distal part and a transverse through opening disposedbetween the proximal and distal parts, the distal part having an outerwall, the proximal end portion of the tubular part of the plug residinginside the distally protruding structure; and

a spring member including a proximal end segment and first and secondclamping segments that are operatively coupled to the proximal endsegment respectively by first and second arms, the spring member beingconfigured to cause the first and second clamping segments to moveradially apart from one another when a distally applied force is appliedto the proximal end segment, when the actuator is in a first axialposition the first and second clamping segments are urged against theouter wall of the distal part of the actuator, when the actuator is in asecond axial position distal to the first axial position the distal partof the actuator is configured to move distally into the recess in theproximal facing surface of the main body of the plug and the first andsecond clamping segments of the spring member move radially inward intothe transverse through opening of the actuator to act against theproximal end portion of the tubular part of the plug in a mannersufficient to cause a closing of the axial through opening of the plugin the proximal end portion.

Clause 2. The catheter assembly according to clause 1, wherein theproximal part of the actuator has an outer wall that tapers distallyinward, when the actuator is in the second axial position the actuatoris movable distally to a third axial position to cause the tapered outerwall of the first part of the actuator to act on the first and secondclamping segments in a manner that results in the first and secondclamping segments to move radially outward in a manner sufficient to atleast partially open the axial through opening of the plug.

Clause 3. The catheter assembly according to clause 1, wherein when theactuator transitions from the first axial position to the second axialposition the actuator is incapable of reassuming the first axialposition.

Clause 4. The catheter assembly according to clause 2, wherein when theactuator transitions from the first axial position to the second axialposition the actuator is incapable of reassuming the first axialposition.

Clause 5. The catheter assembly according to clause 1, wherein theproximal end segment of the spring member abuts a distal facing surfaceof the proximal flange of the actuator and each of the first and secondclamping segments abuts the proximal facing surface of the main body ofthe plug.

Clause 6. The catheter assembly according to clause 1, wherein theproximal flange of the actuator has a first diameter dimension and thedistally protruding part of the actuator has a second diameter dimensionthat is less than the first diameter dimension.

Clause 7. The catheter assembly according to clause 1, wherein the axialthrough opening of the actuator comprises a key-hole shape.

Clause 8. The catheter assembly according to clause 1, wherein thedistal facing surface of the main body of the plug is configured to abutthe distal wall of the catheter hub.

Clause 9. The catheter assembly according to clause 1, wherein a pressfit exists between the main body of the plug and the one or moresidewalls of the catheter hub.

Clause 10. The catheter assembly according to clause 1, furthercomprising an annular plate disposed between the first and secondclamping segments of the spring member and the proximal facing surfaceof the main body of the plug.

Clause 11. The catheter assembly according to clause 10, wherein thefirst and second clamping segments of the spring member abut a proximalfacing surface of the annular plate.

Clause 12. The catheter assembly according to clause 11, wherein themain body of the plug is made of a first material having a firstdurometer and the annular plate is made of a second material having asecond durometer that is greater than the first durometer.

Clause 13. The catheter assembly according to clause 11, wherein theproximal facing surface of the annular plate has a first surfaceroughness and the proximally facing surface of the main body of the plughas a second surface roughness that is greater than the first surfaceroughness.

Clause 14. The catheter assembly according to clause 12, wherein theproximal facing surface of the annular plate has a first surfaceroughness and the proximally facing surface of the main body of the plughas a second surface roughness that is greater than the first surfaceroughness.

Clause 15. The catheter assembly according to clause 1, wherein theouter wall of the distal part of the actuator includes an indentation inwhich the first and second clamping segments of the spring member residewhen the actuator is in the first axial position, the indentationconfigured to assist in holding the first and second clamping segmentson the distal part of the actuator.

Clause 16. The catheter assembly according to clause 1, furthercomprising a ferrule positioned between the distal wall of the catheterhub and the distal facing surface of the main body of the plug.

Clause 17. The catheter assembly according to clause 16, furthercomprising an elongate tube having a proximal end and a distal end, theproximal end being secured to the ferrule.

Clause 18. The catheter assembly according to clause 1, furthercomprising an introducer needle having a proximal end portion, asharpened distal tip and a shaft extending between the proximal end andthe sharpened distal tip, the shaft extending through the axial throughopening the plug and the axial through opening of the actuator when theactuator is in the second axial position.

Clause 19. The catheter assembly according to clause 18, furthercomprising an elongate catheter tube having a proximal end, a distal endand an inner lumen extending through and between the proximal and distalends, the proximal end of the catheter tube being fixed to a distal endportion of the catheter hub, the shaft of the introducer needleextending through the inner lumen of the catheter tube.

Clause 20. The catheter assembly according to clause 18, wherein theproximal end portion of the introducer needle is coupled to a needlehub, the needle hub being detachably coupled to a proximal end of thecatheter hub.

Clause 21. The catheter assembly according to clause 20, wherein theneedle hub has a distally facing surface that presses against theproximal facing surface of the proximal flange of the actuator to causethe actuator to transition from the first axial position to the secondaxial position.

Clause 22. The catheter assembly according to clause 18, wherein theshaft of the introducer needle has a first diameter and the innerdiameter of the axial through opening extending through the proximal endportion of tubular part of the plug having a second diameter dimension,the first diameter dimension being no more than 20% greater than thesecond diameter dimension.

Clause 23. The catheter assembly according to clause 1, wherein theproximal facing surface of the main body of the plug has applied theretoa lubricious film, the first and second clamping segments of the springmember being positioned on a surface of the lubricious film.

Clause 24. The catheter assembly according to clause 20, wherein thesharpened distal tip of the introducer needle is retractable into theneedle hub.

Clause 25. The catheter assembly according to clause 20, furthercomprising a needle guard disposed between the distally facing surfaceof the needle hub and the proximal flange of the actuator.

Clause 26. The catheter assembly according to clause 25, wherein theneedle guard has a distally facing surface that presses against theproximal facing surface of the proximal flange of the actuator to causethe actuator to transition from the first axial position to the secondaxial position.

Group C Clauses:

Clause 1. A valve assembly configured for placement inside a hub thathas a proximal opening, a distal opening and an internal cavity disposedbetween the proximal and distal openings, the cavity defined by one ormore sidewalls and a distal wall, the distal opening extending throughthe distal wall, the valve assembly comprising:

a plug made of a resilient material, the plug including a main bodyhaving a proximal facing surface and a distal facing surface, the mainbody including an axial through opening and being configured such thatthe axial through opening is in fluid communication with the distalopening of the hub, the axial through opening extending through atubular part that has a proximal end portion that protrudes proximal tothe proximal facing surface of the main body, there existing a recess inthe proximal facing surface that at least partially surrounds thetubular part;

an actuator including a proximal flange having a proximal facingsurface, the actuator including a distally protruding structure thatextends distal to the proximal flange, there being an axial throughopening that extends through the proximal flange and the distallyprotruding structure, the distally protruding structure having aproximal part, a distal part and a transverse through opening disposedbetween the proximal and distal parts, the distal part having an outerwall, the proximal end portion of the tubular part of the plug residinginside the distally protruding structure;

a clamping device having first and second clamping arms that areresiliently urged inward toward one another, the clamping device havingan axial through opening through which the distally protruding structureof the actuator passes, when the actuator is in a first axial positionthe first and second clamping arms are urged against the outer wall ofthe distal part of the actuator, when the actuator is in a second axialposition distal to the first axial position the distal part of theactuator is configured to move distally into the recess in the proximalfacing surface of the main body of the plug and the first and secondclamping arms move radially inward into the transverse through openingof the actuator to act against the proximal end portion of the tubularpart of the plug in a manner sufficient to cause a closing of the axialthrough opening of the plug at the proximal end portion; and

a spring that acts on the actuator to urge the actuator in a proximaldirection when the actuator is in the second axial position.

Clause 2. The valve assembly according to clause 1, wherein the proximalpart of the actuator has an outer wall that tapers distally inward, whenthe actuator is in the second axial position the actuator is movabledistally to a third axial position to cause the tapered outer wall ofthe first part of the actuator to act on the first and second clampingarms in a manner that results in the first and second clamping arms tomove radially outward in a manner sufficient to at least partially openthe axial through opening of the plug.

Clause 3. The valve assembly according to clause 1, wherein when theactuator transitions from the first axial position to the second axialposition the actuator is incapable of reassuming the first axialposition.

Clause 4. The valve assembly according to clause 2, wherein when theactuator transitions from the first axial position to the second axialposition the actuator is incapable of reassuming the first axialposition.

Clause 5. The valve assembly according to clause 1, wherein the springhas a proximal end that abuts a distal facing surface of the proximalflange of the actuator and a distal end that abuts the proximal facingsurface of the main body of the plug.

Clause 6. The valve assembly according to clause 1, wherein the firstand second clamping arms are urged radially inward at least in part by aresilient O-ring that circumscribes the clamping device.

Clause 7. The valve assembly according to clause 1, wherein the proximalflange of the actuator has a first diameter dimension and the distallyprotruding part of the actuator has a second diameter dimension that isless than the first diameter dimension.

Clause 8. The valve assembly according to clause 1, wherein the axialthrough opening of the actuator comprises a key-hole shape.

Clause 9. The valve assembly according to clause 1, wherein the distalfacing surface of the main body of the plug is configured to abut thedistal wall of the hub.

Clause 10. The valve assembly according to clause 1, wherein a press fitexists between the main body of the plug and the one or more sidewallsof the hub.

Clause 11. The valve assembly according to clause 1, wherein theclamping device has a distal facing surface that abuts the proximalfacing surface of the main body of the plug.

Clause 12. The valve assembly according to clause 1, further comprisingan annular plate disposed between a distal facing surface of theclamping device and the proximal facing surface of the main body of theplug.

Clause 13. The valve assembly according to clause 12, wherein a distalfacing surface of the clamping device abuts a proximal facing surface ofthe annular plate.

Clause 14. The valve assembly according to clause 13, wherein the mainbody of the plug is made of a first material having a first durometerand the annular plate is made of a second material having a seconddurometer that is greater than the first durometer.

Clause 15. The valve assembly according to clause 13, wherein theproximal facing surface of the annular plate has a first surfaceroughness and the proximally facing surface of the main body of the plughas a second surface roughness that is greater than the first surfaceroughness.

Clause 16. The valve assembly according to clause 14, wherein theproximal facing surface of the annular plate has a first surfaceroughness and the proximally facing surface of the main body of the plughas a second surface roughness that is greater than the first surfaceroughness.

Clause 17. The valve assembly according to clause 1, wherein the outerwall of the distal part of the actuator includes an indentation in whicha distal end segment of the spring resides when the actuator is in thefirst axial position, the indentation configured to assist in holdingthe distal end segment on the distal part of the actuator.

Group D Clauses:

Clause 1. An intravenous catheter comprising:

a catheter hub that has a proximal opening, a distal opening and aninternal cavity disposed between the proximal and distal openings, thecavity defined by one or more sidewalls and a distal wall of thecatheter hub, the distal opening extending through the distal wall;

a plug made of a resilient material, the plug including a main bodyhaving a proximal facing surface and a distal facing surface, the mainbody including an axial through opening and being configured such thatthe axial through opening is in fluid communication with the distalopening of the hub, the axial through opening extending through atubular part that has a proximal end portion that protrudes proximal tothe proximal facing surface of the main body, there existing a recess inthe proximal facing surface that at least partially surrounds thetubular part;

an actuator including a proximal flange having a proximal facingsurface, the actuator including a distally protruding structure thatextends distal to the proximal flange, there being an axial throughopening that extends through the proximal flange and the distallyprotruding structure, the distally protruding structure having aproximal part, a distal part and a transverse through opening disposedbetween the proximal and distal parts, the distal part having an outerwall, the proximal end portion of the tubular part of the plug residinginside the distally protruding structure;

a clamping device having first and second clamping arms that areresiliently urged inward toward one another, the clamping device havingan axial through opening through which the distally protruding structureof the actuator passes, when the actuator is in a first axial positionthe first and second clamping arms are urged against the outer wall ofthe distal part of the actuator, when the actuator is in a second axialposition distal to the first axial position the distal part of theactuator is configured to move distally into the recess in the proximalfacing surface of the main body of the plug and the first and secondclamping arms move radially inward into the transverse through openingof the actuator to act against the proximal end portion of the tubularpart of the plug in a manner sufficient to cause a closing of the axialthrough opening of the plug at the proximal end portion; and

a spring that acts on the actuator to urge the actuator in a proximaldirection when the actuator is in the second axial position.

Clause 2. The catheter assembly according to clause 1, wherein theproximal part of the actuator has an outer wall that tapers distallyinward, when the actuator is in the second axial position the actuatoris movable distally to a third axial position to cause the tapered outerwall of the first part of the actuator to act on the first and secondclamping arms in a manner that results in the first and second clampingarms to move radially outward in a manner sufficient to at leastpartially open the axial through opening of the plug.

Clause 3. The catheter assembly according to clause 1, wherein when theactuator transitions from the first axial position to the second axialposition the actuator is incapable of reassuming the first axialposition.

Clause 4. The catheter assembly according to clause 2, wherein when theactuator transitions from the first axial position to the second axialposition the actuator is incapable of reassuming the first axialposition.

Clause 5. The catheter assembly according to clause 1, wherein thespring has a proximal end and a distal end, the proximal end of thespring abutting a distal facing surface of the proximal flange of ehactuator, the distal end of the spring abutting the proximal facingsurface of the main body of the plug.

Clause 6. The catheter assembly according to clause 1, wherein theproximal flange of the actuator has a first diameter dimension and thedistally protruding part of the actuator has a second diameter dimensionthat is less than the first diameter dimension.

Clause 7. The catheter assembly according to clause 1, wherein the axialthrough opening of the actuator comprises a key-hole shape.

Clause 8. The catheter assembly according to clause 1, wherein thedistal facing surface of the main body of the plug is configured to abutthe distal wall of the catheter hub.

Clause 9. The catheter assembly according to clause 1, wherein a pressfit exists between the main body of the plug and the one or moresidewalls of the catheter hub.

Clause 10. The catheter assembly according to clause 1, furthercomprising an annular plate disposed between the first and secondclamping segments of the spring member and the proximal facing surfaceof the main body of the plug.

Clause 11. The catheter assembly according to clause 10, wherein thefirst and second clamping segments of the spring member abut a proximalfacing surface of the annular plate.

Clause 12. The catheter assembly according to clause 11, wherein themain body of the plug is made of a first material having a firstdurometer and the annular plate is made of a second material having asecond durometer that is greater than the first durometer.

Clause 13. The catheter assembly according to clause 11, wherein theproximal facing surface of the annular plate has a first surfaceroughness and the proximally facing surface of the main body of the plughas a second surface roughness that is greater than the first surfaceroughness.

Clause 14. The catheter assembly according to clause 12, wherein theproximal facing surface of the annular plate has a first surfaceroughness and the proximally facing surface of the main body of the plughas a second surface roughness that is greater than the first surfaceroughness.

Clause 15. The catheter assembly according to clause 1, wherein theouter wall of the distal part of the actuator includes an indentation inwhich the first and second clamping segments of the spring member residewhen the actuator is in the first axial position, the indentationconfigured to assist in holding the first and second clamping segmentson the distal part of the actuator.

Clause 16. The catheter assembly according to clause 1, furthercomprising a ferrule positioned between the distal wall of the catheterhub and the distal facing surface of the main body of the plug.

Clause 17. The catheter assembly according to clause 16, furthercomprising an elongate tube having a proximal end and a distal end, theproximal end being secured to the ferrule.

Clause 18. The catheter assembly according to clause 1, furthercomprising an introducer needle having a proximal end portion, asharpened distal tip and a shaft extending between the proximal end andthe sharpened distal tip, the shaft extending through the axial throughopening the plug and the axial through opening of the actuator when theactuator is in the second axial position.

Clause 19. The catheter assembly according to clause 18, furthercomprising an elongate catheter tube having a proximal end, a distal endand an inner lumen extending through and between the proximal and distalends, the proximal end of the catheter tube being coupled to a distalend portion of the catheter hub, the shaft of the introducer needleextending through the inner lumen of the catheter tube.

Clause 20. The catheter assembly according to clause 18, wherein theproximal end portion of the introducer needle is coupled to a needlehub, the needle hub being detachably coupled to a proximal end of thecatheter hub.

Clause 21. The catheter assembly according to clause 20, wherein theneedle hub has a distally facing surface that presses against theproximal facing surface of the proximal flange of the actuator to causethe actuator to transition from the first axial position to the secondaxial position

Clause 22. The catheter assembly according to clause 18, wherein theshaft of the introducer needle has a first diameter and the innerdiameter of the axial through opening extending through the proximal endportion of tubular part of the plug having a second diameter dimension,the first diameter dimension being no more than 20% greater than thesecond diameter dimension.

Clause 23. The catheter assembly according to clause 1, wherein theproximal facing surface of the main body of the plug has applied theretoa lubricious film, the first and second clamping segments of the springmember being positioned on a surface of the lubricious film.

Clause 24. The catheter assembly according to clause 20, wherein thesharpened distal tip of the introducer needle is retractable into theneedle hub.

Clause 25. The catheter assembly according to clause 20, furthercomprising a needle guard disposed between the distally facing surfaceof the needle hub and the proximal flange of the actuator.

Clause 26. The catheter assembly according to clause 25, wherein theneedle guard has a distally facing surface that presses against theproximal facing surface of the proximal flange of the actuator to causethe actuator to transition from the first axial position to the secondaxial position.

Group E Clauses:

Clause 1. An assembly comprising:

a hub having a proximal opening, a distal opening and an internal cavitydisposed between the proximal and distal openings, the cavity defined byone or more sidewalls and a bottom wall of the hub, the distal openingextending through the bottom wall:

a catheter tube secured to a distal end of the hub and having an innerlumen in fluid communication with the distal opening of the hub;

a valve located inside the hub, the valve including a proximal flange, adistal flange and a tubular part extending between the proximal anddistal flanges, the valve being configured to assume an open positionand closed position, the valve being made of a resilient material andconstructed such that the valve is continuously urged toward the closedposition, in the open position fluid flow is permitted through anopening that extends through the proximal and distal flanges and thetubular part, in the closed position fluid flow is impeded through theopening, the valve being constructed such that when a distally appliedforce is applied to a proximal face of the proximal flange the valvetransitions from the closed position to the open position andsubsequently returns to the closed position when the distally appliedforce is removed.

Clause 2. The assembly according to clause 1, wherein a distal face ofthe distal flange abuts the bottom wall of the hub.

Clause 3. The assembly according to clause 2, wherein the distal flangeincludes an opening that communicates the tubular part of the valve withthe catheter tube when the valve is in the open position and in theclosed position.

Clause 4. The assembly according to clause 1, wherein the proximal faceof the proximal flange is arranged at a first angle with respect to alongitudinal axis of the hub when the valve is in the open position andis arranged at a second angle with respect to the longitudinal axis ofthe hub when the valve is in the closed position, the first angle beinggreater than the second angle.

Clause 5. The assembly according to clause 1, wherein the distal flangehas a circumferential surface that presses against the one or moresidewalls of the hub to hold the valve securely inside the cavity of thehub.

Clause 6. The assembly according to clause 1, wherein the distal flangehas a circumferential surface that presses against the one or moresidewalls of the hub to hold the valve securely inside the cavity of thehub without the use of an adhesive.

Clause 7. The assembly according to clause 1, wherein the proximalflange has a first diameter when the valve is in the open position and asecond diameter when the valve is in the closed position, the firstdiameter being greater than the second diameter.

Clause 8. The assembly according to clause 1, wherein the tubular partof the valve has walls that press against one another to impede fluidflow through the tubular part when the valve is in the closed positionand the walls do not press against one another to permit fluid flowthrough the tubular part when the valve is in the open position.

Clause 9. An assembly comprising:

a hub having a proximal opening, a distal opening and an internal cavitydisposed between the proximal and distal openings, the cavity defined byone or more sidewalls and a bottom wall of the hub, the distal openingextending through the bottom wall:

a catheter tube secured to a distal end of the hub and having an innerlumen in fluid communication with the distal opening of the hub;

an introducer needle residing in the catheter tube and having an outerwall and a distal tip, the distal tip extending distally from a distalend of the catheter tube,

a valve disposed about the introducer needle inside the hub, the valveincluding a proximal flange, a distal flange and a tubular partextending between the proximal and distal flanges, the valve beingconfigured to assume an open position and a closed position, in the openposition a through passage is provided that extends through the proximaland distal flanges and the tubular part, in the closed position thethrough passage is closed, the valve being made of a resilient materialand constructed such that the valve is continuously urged toward theclosed position, when the introducer needle resides inside the cathetertube the outer wall of the introducer needle causes the valve to assumethe open position, when the introducer needle is removed from thecatheter tube the valve assumes the closed position, when the valve isin the closed position the valve is constructed such that when adistally applied force is applied to a proximal face of the proximalflange the valve transitions from the closed position to the openposition and subsequently returns to the closed position when thedistally applied force is removed.

Group F Clauses:

Clause 1. An assembly comprising:

a hub having a proximal opening, a distal opening and an internal cavitydisposed between the proximal and distal openings, the cavity defined byone or more sidewalls and a bottom wall of the hub, the distal openingextending through the bottom wall;

a catheter tube secured to a distal end of the hub and having a tubularwall with an inner surface that defines an inner lumen, the cathetertube having a proximal portion that resides inside the cavity of the huband a distal portion that resides outside the hub, the proximal portionhaving an outer surface;

a valve located inside the hub that is transitional between an openposition and a closed position, the valve including a base having athrough opening through which a portion of the catheter tube passes, thevalve including first and second arms that are positioned about theouter surface of the proximal portion of the catheter tube, each of thefirst and second arms including a first section having a distal end anda proximal end, the distal end of the first section being coupled to thebase, the proximal end of the first section being disposed radiallyinward of the distal end of the first section, each of the first andsecond arms including a second section having a distal end and aproximal end, the distal end of the second section being coupled to thedistal end of the first section, the proximal end of the second sectionbeing disposed radially outward of the distal end of the section, theproximal end of the first section of the first arm being coupled to thedistal end of the second section of the first arm at a first location,the proximal end of the first section of the second arm being coupled tothe distal end of the second section of the second arm at a secondlocation, each of the first and second arms being made of a resilientmaterial and constructed such that the first and second locations arecontinuously urged toward one another to position the valve in theclosed position, in the closed position of the valve the first andsecond locations press against the outer surface of the proximal portionof the catheter tube to cause a collapse of the tubular wall in theproximal portion that results in a full or substantially full closing ofthe inner lumen of the catheter tube, in the open position of the valvethe first and second locations are positioned radially apart from oneanother so as not to press against the outer surface of the proximalportion of the catheter tube that results in a full or substantiallyfull opening.

What is claimed is:
 1. An assembly comprising: a hub having a proximalopening, a distal opening and an internal cavity disposed between theproximal and distal openings, the cavity defined by one or moresidewalls and a bottom wall of the hub, the distal opening extendingthrough the bottom wall: a catheter tube secured to a distal end of thehub and having an inner lumen in fluid communication with the distalopening of the hub; a valve located inside the hub, the valve includinga proximal flange, a distal flange and a tubular part extending betweenthe proximal and distal flanges, the valve being configured to assume anopen position and closed position, the valve being made of a resilientmaterial and constructed such that the valve is continuously urgedtoward the closed position, in the open position fluid flow is permittedthrough an opening that extends through the proximal and distal flangesand the tubular part, in the closed position fluid flow is impededthrough the opening, the valve being constructed such that when adistally applied force is applied to a proximal face of the proximalflange the valve transitions from the closed position to the openposition and subsequently returns to the closed position when thedistally applied force is removed.
 2. The assembly according to claim 1,wherein a distal face of the distal flange abuts the bottom wall of thehub.
 3. The assembly according to claim 2, wherein the distal flangeincludes an opening that communicates the tubular part of the valve withthe catheter tube when the valve is in the open position and in theclosed position.
 4. The assembly according to claim 1, wherein theproximal face of the proximal flange is arranged at a first angle withrespect to a longitudinal axis of the hub when the valve is in the openposition and is arranged at a second angle with respect to thelongitudinal axis of the hub when the valve is in the closed position,the first angle being greater than the second angle.
 5. The assemblyaccording to claim 1, wherein the distal flange has a circumferentialsurface that presses against the one or more sidewalls of the hub tohold the valve securely inside the cavity of the hub.
 6. The assemblyaccording to claim 1, wherein the distal flange has a circumferentialsurface that presses against the one or more sidewalls of the hub tohold the valve securely inside the cavity of the hub without the use ofan adhesive.
 7. The assembly according to claim 1, wherein the proximalflange has a first diameter when the valve is in the open position and asecond diameter when the valve is in the closed position, the firstdiameter being greater than the second diameter.
 8. The assemblyaccording to claim 1, wherein the tubular part of the valve has wallsthat press against one another to impede fluid flow through the tubularpart when the valve is in the closed position and the walls do not pressagainst one another to permit fluid flow through the tubular part whenthe valve is in the open position.
 9. An assembly comprising: a hubhaving a proximal opening, a distal opening and an internal cavitydisposed between the proximal and distal openings, the cavity defined byone or more sidewalls and a bottom wall of the hub, the distal openingextending through the bottom wall: a catheter tube secured to a distalend of the hub and having an inner lumen in fluid communication with thedistal opening of the hub; an introducer needle residing in the cathetertube and having an outer wall and a distal tip, the distal tip extendingdistally from a distal end of the catheter tube, a valve disposed aboutthe introducer needle inside the hub, the valve including a proximalflange, a distal flange and a tubular part extending between theproximal and distal flanges, the valve being configured to assume anopen position and a closed position, in the open position a throughpassage is provided that extends through the proximal and distal flangesand the tubular part, in the closed position the through passage isclosed, the valve being made of a resilient material and constructedsuch that the valve is continuously urged toward the closed position,when the introducer needle resides inside the catheter tube the outerwall of the introducer needle causes the valve to assume the openposition, when the introducer needle is removed from the catheter tubethe valve assumes the closed position, when the valve is in the closedposition the valve is constructed such that when a distally appliedforce is applied to a proximal face of the proximal flange the valvetransitions from the closed position to the open position andsubsequently returns to the closed position when the distally appliedforce is removed.